21 CFR 868.1720 — Analyzer, Gas, Oxygen, Gaseous-Phase
Anesthesiology (AN) · Part 868 Subpart B—Diagnostic Devices · § 868.1720
Identification
An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 2 | 121 | 3rd Party |
