Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1700](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1700) → CBR — Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)

# CBR · Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)

_Anesthesiology · 21 CFR 868.1700 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBR

## Overview

- **Product Code:** CBR
- **Device Name:** Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
- **Regulation:** [21 CFR 868.1700](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1700)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)
- **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](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBR/K112173.md) | SPEACELABS MULTIGAS MODULE | Spacelabs Healthcare | Oct 5, 2011 | SESE |
| [K053599](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBR/K053599.md) | SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES | Spacelabs Medical, Inc. | Apr 19, 2006 | SESE |
| [K954962](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBR/K954962.md) | SPACELABS MEDICAL MULTIGAS ANALYZER | Spacelabs, Inc. | May 31, 1996 | SESE |
| [K904843](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBR/K904843.md) | OSCAR(TM) II CAPNOMETER & PULSE OXIMETER | Dalton Instrument Corp. | Apr 9, 1991 | SESE |
| [K853360](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBR/K853360.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBR](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBR)

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