← Product Code [CCL](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCL) · K910381

# BIOCHEM TEMPERATURE/ FIO2 MODULE (K910381)

_Biochem International, Inc. · CCL · Aug 22, 1991 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCL/K910381

## Device Facts

- **Applicant:** Biochem International, Inc.
- **Product Code:** [CCL](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCL.md)
- **Decision Date:** Aug 22, 1991
- **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/K910381](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCL/K910381)

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