← Product Code [CCL](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCL) · K812040

# OXYGEN MONITOR 140/141 (K812040)

_Medix Medical Electronics (U.S.A.), Inc. · CCL · Sep 21, 1981 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCL/K812040

## Device Facts

- **Applicant:** Medix Medical Electronics (U.S.A.), Inc.
- **Product Code:** [CCL](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCL.md)
- **Decision Date:** Sep 21, 1981
- **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/K812040](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCL/K812040)

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