← Product Code [CCL](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCL) · K894918

# HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP. (K894918)

_Mennen Medical, Inc. · CCL · Oct 31, 1989 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCL/K894918

## Device Facts

- **Applicant:** Mennen Medical, Inc.
- **Product Code:** [CCL](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCL.md)
- **Decision Date:** Oct 31, 1989
- **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/K894918](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCL/K894918)

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