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Title 21 - Title 21
Part 868 - ANESTHESIOLOGY DEVICES
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MEDICAL DEVICES - ANESTHESIOLOGY DEVICES
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147 sections
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§868.1 - Scope.
Title 21, Part 868
§868.1030 - Manual algesimeter.
Title 21, Part 868
§868.1040 - Powered algesimeter.
Title 21, Part 868
§868.1075 - Argon gas analyzer.
Title 21, Part 868
§868.1100 - Arterial blood sampling kit.
Title 21, Part 868
§868.1120 - Indwelling blood oxyhemoglobin concentration analyzer.
Title 21, Part 868
§868.1150 - Indwelling blood carbon dioxide partial pressure (P
Title 21, Part 868
§868.1170 - Indwelling blood hydrogen ion concentration (pH) analyzer.
Title 21, Part 868
§868.1200 - Indwelling blood oxygen partial pressure (P
Title 21, Part 868
§868.1400 - Carbon dioxide gas analyzer.
Title 21, Part 868
§868.1430 - Carbon monoxide gas analyzer.
Title 21, Part 868
§868.1500 - Enflurane gas analyzer.
Title 21, Part 868
§868.1575 - Gas collection vessel.
Title 21, Part 868
§868.1620 - Halothane gas analyzer.
Title 21, Part 868
§868.1640 - Helium gas analyzer.
Title 21, Part 868
§868.1670 - Neon gas analyzer.
Title 21, Part 868
§868.1690 - Nitrogen gas analyzer.
Title 21, Part 868
§868.1700 - Nitrous oxide gas analyzer.
Title 21, Part 868
§868.1720 - Oxygen gas analyzer.
Title 21, Part 868
§868.1730 - Oxygen uptake computer.
Title 21, Part 868
§868.1750 - Pressure plethysmograph.
Title 21, Part 868
§868.1760 - Volume plethysmograph.
Title 21, Part 868
§868.1780 - Inspiratory airway pressure meter.
Title 21, Part 868
§868.1800 - Rhinoanemometer.
Title 21, Part 868
§868.1840 - Diagnostic spirometer.
Title 21, Part 868
§868.1850 - Monitoring spirometer.
Title 21, Part 868
§868.1860 - Peak-flow meter for spirometry.
Title 21, Part 868
§868.1870 - Gas volume calibrator.
Title 21, Part 868
§868.1880 - Pulmonary-function data calculator.
Title 21, Part 868
§868.1890 - Predictive pulmonary-function value calculator.
Title 21, Part 868
§868.1900 - Diagnostic pulmonary-function interpretation calculator.
Title 21, Part 868
§868.1910 - Esophageal stethoscope.
Title 21, Part 868
§868.1920 - Esophageal stethoscope with electrical conductors.
Title 21, Part 868
§868.1930 - Stethoscope head.
Title 21, Part 868
§868.1965 - Switching valve (ploss).
Title 21, Part 868
§868.1975 - Water vapor analyzer.
Title 21, Part 868
§868.2025 - Ultrasonic air embolism monitor.
Title 21, Part 868
§868.2300 - Bourdon gauge flowmeter.
Title 21, Part 868
§868.2320 - Uncompensated thorpe tube flowmeter.
Title 21, Part 868
§868.2340 - Compensated thorpe tube flowmeter.
Title 21, Part 868
§868.2350 - Gas calibration flowmeter.
Title 21, Part 868
§868.2375 - Breathing frequency monitor.
Title 21, Part 868
§868.2377 - Apnea monitor.
Title 21, Part 868
§868.2380 - Nitric oxide analyzer.
Title 21, Part 868
§868.2385 - Nitrogen dioxide analyzer.
Title 21, Part 868
§868.2450 - Lung water monitor.
Title 21, Part 868
§868.2480 - Cutaneous carbon dioxide (PcCO2) monitor.
Title 21, Part 868
§868.2500 - Cutaneous oxygen (PcO2) monitor.
Title 21, Part 868
§868.2550 - Pneumotachometer.
Title 21, Part 868
§868.2600 - Airway pressure monitor.
Title 21, Part 868
§868.2610 - Gas pressure gauge.
Title 21, Part 868
§868.2620 - Gas pressure calibrator.
Title 21, Part 868
§868.2700 - Pressure regulator.
Title 21, Part 868
§868.2775 - Electrical peripheral nerve stimulator.
Title 21, Part 868
§868.2875 - Differential pressure transducer.
Title 21, Part 868
§868.2885 - Gas flow transducer.
Title 21, Part 868
§868.2900 - Gas pressure transducer.
Title 21, Part 868
§868.3 - Effective dates of requirement for premarket approval.
Title 21, Part 868
§868.5090 - Emergency airway needle.
Title 21, Part 868
§868.5100 - Nasopharyngeal airway.
Title 21, Part 868
§868.5105 - External negative pressure airway aid.
Title 21, Part 868
§868.5110 - Oropharyngeal airway.
Title 21, Part 868
§868.5115 - Device to relieve acute upper airway obstruction.
Title 21, Part 868
§868.5120 - Anesthesia conduction catheter.
Title 21, Part 868
§868.5130 - Anesthesia conduction filter.
Title 21, Part 868
§868.5140 - Anesthesia conduction kit.
Title 21, Part 868
§868.5150 - Anesthesia conduction needle.
Title 21, Part 868
§868.5160 - Gas machine for anesthesia or analgesia.
Title 21, Part 868
§868.5165 - Nitric oxide administration apparatus.
Title 21, Part 868
§868.5170 - Laryngotracheal topical anesthesia applicator.
Title 21, Part 868
§868.5180 - Rocking bed.
Title 21, Part 868
§868.5220 - Blow bottle.
Title 21, Part 868
§868.5240 - Anesthesia breathing circuit.
Title 21, Part 868
§868.5250 - Breathing circuit circulator.
Title 21, Part 868
§868.5260 - Breathing circuit bacterial filter.
Title 21, Part 868
§868.5270 - Breathing system heater.
Title 21, Part 868
§868.5273 - Positive airway pressure delivery system.
Title 21, Part 868
§868.5280 - Breathing tube support.
Title 21, Part 868
§868.5300 - Carbon dioxide absorbent.
Title 21, Part 868
§868.5310 - Carbon dioxide absorber.
Title 21, Part 868
§868.5320 - Reservoir bag.
Title 21, Part 868
§868.5330 - Breathing gas mixer.
Title 21, Part 868
§868.5340 - Nasal oxygen cannula.
Title 21, Part 868
§868.5350 - Nasal oxygen catheter.
Title 21, Part 868
§868.5365 - Posture chair for cardiac or pulmonary treatment.
Title 21, Part 868
§868.5375 - Heat and moisture condenser (artificial nose).
Title 21, Part 868
§868.5400 - Electroanesthesia apparatus.
Title 21, Part 868
§868.5420 - Ether hook.
Title 21, Part 868
§868.5430 - Gas-scavenging apparatus.
Title 21, Part 868
§868.5440 - Portable oxygen generator.
Title 21, Part 868
§868.5450 - Respiratory gas humidifier.
Title 21, Part 868
§868.5454 - High flow humidified oxygen delivery device.
Title 21, Part 868
§868.5460 - Therapeutic humidifier for home use.
Title 21, Part 868
§868.5470 - Hyperbaric chamber.
Title 21, Part 868
§868.5530 - Flexible laryngoscope.
Title 21, Part 868
§868.5540 - Rigid laryngoscope.
Title 21, Part 868
§868.5550 - Anesthetic gas mask.
Title 21, Part 868
§868.5560 - Gas mask head strap.
Title 21, Part 868
§868.5570 - Nonrebreathing mask.
Title 21, Part 868
§868.5580 - Oxygen mask.
Title 21, Part 868
§868.5590 - Scavenging mask.
Title 21, Part 868
§868.5600 - Venturi mask.
Title 21, Part 868
§868.5620 - Breathing mouthpiece.
Title 21, Part 868
§868.5630 - Nebulizer.
Title 21, Part 868
§868.5640 - Medicinal nonventilatory nebulizer (atomizer).
Title 21, Part 868
§868.5650 - Esophageal obturator.
Title 21, Part 868
§868.5655 - Portable liquid oxygen unit.
Title 21, Part 868
§868.5665 - Powered percussor.
Title 21, Part 868
§868.5675 - Rebreathing device.
Title 21, Part 868
§868.5690 - Incentive spirometer.
Title 21, Part 868
§868.5700 - Nonpowered oxygen tent.
Title 21, Part 868
§868.5710 - Electrically powered oxygen tent.
Title 21, Part 868
§868.5720 - Bronchial tube.
Title 21, Part 868
§868.5730 - Tracheal tube.
Title 21, Part 868
§868.5740 - Tracheal/bronchial differential ventilation tube.
Title 21, Part 868
§868.5750 - Inflatable tracheal tube cuff.
Title 21, Part 868
§868.5760 - Cuff spreader.
Title 21, Part 868
§868.5770 - Tracheal tube fixation device.
Title 21, Part 868
§868.5780 - Tube introduction forceps.
Title 21, Part 868
§868.5790 - Tracheal tube stylet.
Title 21, Part 868
§868.5795 - Tracheal tube cleaning brush.
Title 21, Part 868
§868.5800 - Tracheostomy tube and tube cuff.
Title 21, Part 868
§868.5810 - Airway connector.
Title 21, Part 868
§868.5820 - Dental protector.
Title 21, Part 868
§868.5830 - Autotransfusion apparatus.
Title 21, Part 868
§868.5860 - Pressure tubing and accessories.
Title 21, Part 868
§868.5870 - Nonrebreathing valve.
Title 21, Part 868
§868.5880 - Anesthetic vaporizer.
Title 21, Part 868
§868.5895 - Continuous ventilator.
Title 21, Part 868
§868.5905 - Noncontinuous ventilator (IPPB).
Title 21, Part 868
§868.5915 - Manual emergency ventilator.
Title 21, Part 868
§868.5925 - Powered emergency ventilator.
Title 21, Part 868
§868.5935 - External negative pressure ventilator.
Title 21, Part 868
§868.5955 - Intermittent mandatory ventilation attachment.
Title 21, Part 868
§868.5965 - Positive end expiratory pressure breathing attachment.
Title 21, Part 868
§868.5975 - Ventilator tubing.
Title 21, Part 868
§868.5995 - Tee drain (water trap).
Title 21, Part 868
§868.6100 - Anesthetic cabinet, table, or tray.
Title 21, Part 868
§868.6175 - Cardiopulmonary emergency cart.
Title 21, Part 868
§868.6225 - Nose clip.
Title 21, Part 868
§868.6250 - Portable air compressor.
Title 21, Part 868
§868.6400 - Calibration gas.
Title 21, Part 868
§868.6700 - Anesthesia stool.
Title 21, Part 868
§868.6810 - Tracheobronchial suction catheter.
Title 21, Part 868
§868.6820 - Patient position support.
Title 21, Part 868
§868.6885 - Medical gas yoke assembly.
Title 21, Part 868
§868.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
Title 21, Part 868