← Product Code [CCJ](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ) · K952694

# CO  BREATH ANALYSIS MODULE & MONOXOL II (K952694)

_Bacharach, Inc. · CCJ · Jan 29, 1996 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K952694

## Device Facts

- **Applicant:** Bacharach, Inc.
- **Product Code:** [CCJ](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ.md)
- **Decision Date:** Jan 29, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.1430
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

A carbon monoxide gas analyzer is a device intended to measure the concentration of carbon monoxide in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as infrared absorption or gas chromatography.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K952694](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K952694)

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