JEG · Analyzer, Gas, Argon, Gaseous-Phase
Anesthesiology · 21 CFR 868.1075 · Class 2
Overview
| Product Code | JEG |
|---|---|
| Device Name | Analyzer, Gas, Argon, Gaseous-Phase |
| Regulation | 21 CFR 868.1075 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
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).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K880442 | BRUSHRITE | Pro Care Laboratories, Inc. | May 16, 1988 | SESE |
Top Applicants
- Pro Care Laboratories, Inc. — 1 clearance
