CBR · Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
Anesthesiology · 21 CFR 868.1700 · Class 2
Overview
| Product Code | CBR |
|---|---|
| Device Name | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) |
| Regulation | 21 CFR 868.1700 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
A nitrous oxide gas analyzer is a device intended to measure the concentration of nitrous oxide anesthetic in a gas mixture. The device may use techniques such as infrared absorption or mass spectrometry.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K112173 | SPEACELABS MULTIGAS MODULE | Spacelabs Healthcare | Oct 5, 2011 | SESE |
| K053599 | SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES | Spacelabs Medical, Inc. | Apr 19, 2006 | SESE |
| K954962 | SPACELABS MEDICAL MULTIGAS ANALYZER | Spacelabs, Inc. | May 31, 1996 | SESE |
| K904843 | OSCAR(TM) II CAPNOMETER & PULSE OXIMETER | Dalton Instrument Corp. | Apr 9, 1991 | SESE |
| K853360 | N20 TEST | Erich Jaeger, Inc. | Sep 3, 1985 | SESE |
Top Applicants
- Dalton Instrument Corp. — 1 clearance
- Erich Jaeger, Inc. — 1 clearance
- Spacelabs Healthcare — 1 clearance
- Spacelabs Medical, Inc. — 1 clearance
- Spacelabs, Inc. — 1 clearance
