BXA · Analyzer, Gas, Water Vapor, Gaseous-Phase
Anesthesiology · 21 CFR 868.1975 · Class 1
Overview
| Product Code | BXA |
|---|---|
| Device Name | Analyzer, Gas, Water Vapor, Gaseous-Phase |
| Regulation | 21 CFR 868.1975 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K771510 | SERVO-PAK MOLEL 0030 | Isothermal Systems, Inc. | Aug 16, 1977 | SESE |
| K760246 | ENDOTRACHEAL T CONNECTOR | Sherwood Medical Industries | Aug 4, 1976 | SESE |
Top Applicants
- Isothermal Systems, Inc. — 1 clearance
- Sherwood Medical Industries — 1 clearance
