← Product Code [CCL](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCL) · K791199

# ANESTHESIA OXYGEN ANALYZER MODEL 101 (K791199)

_Rule Medical Instruments, Inc. · CCL · Aug 3, 1979 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCL/K791199

## Device Facts

- **Applicant:** Rule Medical Instruments, Inc.
- **Product Code:** [CCL](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCL.md)
- **Decision Date:** Aug 3, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.1720
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCL/K791199](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCL/K791199)

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