21 CFR § 868.1400 - Carbon dioxide gas analyzer.

---
identifier: "/us/cfr/t21/s868.1400"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 868.1400 - Carbon dioxide gas analyzer."
title_number: 21
title_name: "Food and Drugs"
section_number: "868.1400"
section_name: "Carbon dioxide gas analyzer."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "868"
part_name: "ANESTHESIOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "47 FR 31142, July 16, 1982, unless otherwise noted."
cfr_part: "868"
---


# 868.1400 Carbon dioxide gas analyzer.

(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).