21 CFR 868.1620 — Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
Anesthesiology (AN) · Part 868 Subpart B—Diagnostic Devices · § 868.1620
Identification
A halothane gas analyzer is a device intended to measure the concentration of halothane anesthetic in a gas mixture. The device may use techniques such as mass spectrometry or absorption of infrared or ultraviolet radiation.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | 2 | 17 | 3rd Party |