CCI · Analyzer, Gas, Nitrogen, Gaseous-Phase
Anesthesiology · 21 CFR 868.1690 · Class 2
Overview
| Product Code | CCI |
|---|---|
| Device Name | Analyzer, Gas, Nitrogen, Gaseous-Phase |
| Regulation | 21 CFR 868.1690 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
A nitrogen gas analyzer is a device intended to measure the concentration of nitrogen in respiratory gases to aid in determining a patient's ventilatory status. The device may use techniques such as gas chromatography or mass spectrometry.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K872024 | CO2/02 MONITOR MULTINEX | Datascope Corp. | Mar 31, 1988 | SESE |
| K771516 | CAPILLARY SAMPLE LINE | Mcgaw Respiratory Therapy | Aug 16, 1977 | SESE |
Top Applicants
- Datascope Corp. — 1 clearance
- Mcgaw Respiratory Therapy — 1 clearance
