21 CFR 868.1975 — Analyzer, Gas, Water Vapor, Gaseous-Phase
Anesthesiology (AN) · Part 868 Subpart B—Diagnostic Devices · § 868.1975
Identification
A water vapor analyzer is a device intended to measure the concentration of water vapor in a patient's expired gases by using techniques such as mass spectrometry.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BXA | Analyzer, Gas, Water Vapor, Gaseous-Phase | 1 | 2 |
