21 CFR 868.1075 — Analyzer, Gas, Argon, Gaseous-Phase
Anesthesiology (AN) · Part 868 Subpart B—Diagnostic Devices · § 868.1075
Identification
An argon gas analyzer is a device intended to measure the concentration of argon in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as mass spectrometry or thermal conductivity.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JEG | Analyzer, Gas, Argon, Gaseous-Phase | 2 | 1 | 3rd Party |
