21 CFR 868.1400 — Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Anesthesiology (AN) · Part 868 Subpart B—Diagnostic Devices · § 868.1400
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 2 | 304 | 3rd Party |
| OGK | Orotracheal Intubation Guide Kit | 2 | 0 |
