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Title 21 - Title 21

Part 880 - GENERAL HOSPITAL AND PERSONAL USE DEVICES

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Details about Part 880

Description

MEDICAL DEVICES - GENERAL HOSPITAL AND PERSONAL USE DEVICES

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116 sections

§880.1 - Scope.

Title 21, Part 880

§880.2200 - Liquid crystal forehead temperature strip.

Title 21, Part 880

§880.2400 - Bed-patient monitor.

Title 21, Part 880

§880.2420 - Electronic monitor for gravity flow infusion systems.

Title 21, Part 880

§880.2460 - Electrically powered spinal fluid pressure monitor.

Title 21, Part 880

§880.2500 - Spinal fluid manometer.

Title 21, Part 880

§880.2700 - Stand-on patient scale.

Title 21, Part 880

§880.2720 - Patient scale.

Title 21, Part 880

§880.2740 - Surgical sponge scale.

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§880.2750 - Image processing device for estimation of external blood loss.

Title 21, Part 880

§880.2800 - Sterilization process indicator.

Title 21, Part 880

§880.2900 - Clinical color change thermometer.

Title 21, Part 880

§880.2910 - Clinical electronic thermometer.

Title 21, Part 880

§880.2920 - Clinical mercury thermometer.

Title 21, Part 880

§880.2930 - Apgar timer.

Title 21, Part 880

§880.3 - Effective dates of requirement for premarket approval.

Title 21, Part 880

§880.5025 - I.V. container.

Title 21, Part 880

§880.5045 - Medical recirculating air cleaner.

Title 21, Part 880

§880.5075 - Elastic bandage.

Title 21, Part 880

§880.5090 - Liquid bandage.

Title 21, Part 880

§880.5100 - AC-powered adjustable hospital bed.

Title 21, Part 880

§880.5110 - Hydraulic adjustable hospital bed.

Title 21, Part 880

§880.5120 - Manual adjustable hospital bed.

Title 21, Part 880

§880.5130 - Infant radiant warmer.

Title 21, Part 880

§880.5140 - Pediatric medical crib.

Title 21, Part 880

§880.5145 - Medical bassinet.

Title 21, Part 880

§880.5150 - Nonpowered flotation therapy mattress.

Title 21, Part 880

§880.5160 - Therapeutic medical binder.

Title 21, Part 880

§880.5180 - Burn sheet.

Title 21, Part 880

§880.5200 - Intravascular catheter.

Title 21, Part 880

§880.5210 - Intravascular catheter securement device.

Title 21, Part 880

§880.5240 - Medical adhesive tape and adhesive bandage.

Title 21, Part 880

§880.5270 - Neonatal eye pad.

Title 21, Part 880

§880.5300 - Medical absorbent fiber.

Title 21, Part 880

§880.5400 - Neonatal incubator.

Title 21, Part 880

§880.5410 - Neonatal transport incubator.

Title 21, Part 880

§880.5420 - Pressure infusor for an I.V. bag.

Title 21, Part 880

§880.5430 - Nonelectrically powered fluid injector.

Title 21, Part 880

§880.5440 - Intravascular administration set.

Title 21, Part 880

§880.5445 - Intravascular administration set, automated air removal system.

Title 21, Part 880

§880.5450 - Patient care reverse isolation chamber.

Title 21, Part 880

§880.5475 - Jet lavage.

Title 21, Part 880

§880.5500 - AC-powered patient lift.

Title 21, Part 880

§880.5510 - Non-AC-powered patient lift.

Title 21, Part 880

§880.5550 - Alternating pressure air flotation mattress.

Title 21, Part 880

§880.5560 - Temperature regulated water mattress.

Title 21, Part 880

§880.5570 - Hypodermic single lumen needle.

Title 21, Part 880

§880.5580 - Acupuncture needle.

Title 21, Part 880

§880.5630 - Nipple shield.

Title 21, Part 880

§880.5640 - Lamb feeding nipple.

Title 21, Part 880

§880.5680 - Pediatric position holder.

Title 21, Part 880

§880.5700 - Neonatal phototherapy unit.

Title 21, Part 880

§880.5725 - Infusion pump.

Title 21, Part 880

§880.5740 - Suction snakebite kit.

Title 21, Part 880

§880.5760 - Chemical cold pack snakebite kit.

Title 21, Part 880

§880.5780 - Medical support stocking.

Title 21, Part 880

§880.5820 - Therapeutic scrotal support.

Title 21, Part 880

§880.5860 - Piston syringe.

Title 21, Part 880

§880.5950 - Umbilical occlusion device.

Title 21, Part 880

§880.5960 - Lice removal kit.

Title 21, Part 880

§880.5965 - Subcutaneous, implanted, intravascular infusion port and catheter.

Title 21, Part 880

§880.5970 - Percutaneous, implanted, long-term intravascular catheter.

Title 21, Part 880

§880.6025 - Absorbent tipped applicator.

Title 21, Part 880

§880.6050 - Ice bag.

Title 21, Part 880

§880.6060 - Medical disposable bedding.

Title 21, Part 880

§880.6070 - Bed board.

Title 21, Part 880

§880.6080 - Cardiopulmonary resuscitation board.

Title 21, Part 880

§880.6085 - Hot/cold water bottle.

Title 21, Part 880

§880.6100 - Ethylene oxide gas aerator cabinet.

Title 21, Part 880

§880.6140 - Medical chair and table.

Title 21, Part 880

§880.6150 - Ultrasonic cleaner for medical instruments.

Title 21, Part 880

§880.6175 - Unknown

Title 21, Part 880

§880.6185 - Cast cover.

Title 21, Part 880

§880.6190 - Mattress cover for medical purposes.

Title 21, Part 880

§880.6200 - Ring cutter.

Title 21, Part 880

§880.6210 - Sharps needle destruction device.

Title 21, Part 880

§880.6230 - Tongue depressor.

Title 21, Part 880

§880.6250 - Non-powdered patient examination glove.

Title 21, Part 880

§880.6260 - Filtering facepiece respirator for use by the general public in public health medical emergencies.

Title 21, Part 880

§880.6265 - Examination gown.

Title 21, Part 880

§880.6280 - Medical insole.

Title 21, Part 880

§880.6300 - Implantable radiofrequency transponder system for patient identification and health information.

Title 21, Part 880

§880.6305 - Ingestible event marker.

Title 21, Part 880

§880.6310 - Medical device data system.

Title 21, Part 880

§880.6315 - Remote Medication Management System.

Title 21, Part 880

§880.6320 - AC-powered medical examination light.

Title 21, Part 880

§880.6350 - Battery-powered medical examination light.

Title 21, Part 880

§880.6375 - Patient lubricant.

Title 21, Part 880

§880.6430 - Liquid medication dispenser.

Title 21, Part 880

§880.6450 - Skin pressure protectors.

Title 21, Part 880

§880.6500 - Medical ultraviolet air purifier.

Title 21, Part 880

§880.6600 - Ultraviolet (UV) radiation chamber disinfection device.

Title 21, Part 880

§880.6710 - Medical ultraviolet water purifier.

Title 21, Part 880

§880.6730 - Body waste receptacle.

Title 21, Part 880

§880.6740 - Vacuum-powered body fluid suction apparatus.

Title 21, Part 880

§880.6760 - Protective restraint.

Title 21, Part 880

§880.6775 - Powered patient transfer device.

Title 21, Part 880

§880.6785 - Manual patient transfer device.

Title 21, Part 880

§880.6800 - Washers for body waste receptacles.

Title 21, Part 880

§880.6820 - Medical disposable scissors.

Title 21, Part 880

§880.6850 - Sterilization wrap.

Title 21, Part 880

§880.6860 - Ethylene oxide gas sterilizer.

Title 21, Part 880

§880.6870 - Dry-heat sterilizer.

Title 21, Part 880

§880.6880 - Steam sterilizer.

Title 21, Part 880

§880.6885 - Liquid chemical sterilants/high level disinfectants.

Title 21, Part 880

§880.6890 - General purpose disinfectants.

Title 21, Part 880

§880.6900 - Hand-carried stretcher.

Title 21, Part 880

§880.6910 - Wheeled stretcher.

Title 21, Part 880

§880.6920 - Syringe needle introducer.

Title 21, Part 880

§880.6960 - Irrigating syringe.

Title 21, Part 880

§880.6970 - Liquid crystal vein locator.

Title 21, Part 880

§880.6980 - Vein stabilizer.

Title 21, Part 880

§880.6990 - Infusion stand.

Title 21, Part 880

§880.6991 - Medical washer.

Title 21, Part 880

§880.6992 - Medical washer-disinfector.

Title 21, Part 880

§880.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Title 21, Part 880