eCFR Reference Browser

---

title: "21 CFR §868.1400"

source: "https://www.ecfr.gov/current/title-21/section-868.1400"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "868"

part_subject: "ANESTHESIOLOGY DEVICES"

subpart_code: "B"

subpart_subject: "Diagnostic Devices"

section_number: "868.1400"

section_subject: "Carbon dioxide gas analyzer."

cfr_reference: "21 CFR 868.1400"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(a)Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

(b)Classification. Class II (performance standards).

§868.1400 - Carbon dioxide gas analyzer.