21 CFR 868.1640 — Analyzer, Gas, Helium, Gaseous-Phase
Anesthesiology (AN) · Part 868 Subpart B—Diagnostic Devices · § 868.1640
Identification
A helium gas analyzer is a device intended to measure the concentration of helium in a gas mixture during pulmonary function testing. The device may use techniques such as thermal conductivity, gas chromatography, or mass spectrometry.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BSE | Analyzer, Gas, Helium, Gaseous-Phase | 2 | 3 | 3rd Party |
