← Product Code [CCJ](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ) · K950197

# MICROCO (K950197)

_Micro Direct, Inc. · CCJ · Oct 17, 1996 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K950197

## Device Facts

- **Applicant:** Micro Direct, Inc.
- **Product Code:** [CCJ](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ.md)
- **Decision Date:** Oct 17, 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/K950197](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K950197)

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