← Product Code [CCJ](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ) · K892524

# VITALOGRAPH-BREATHCO MONITOR (K892524)

_Vitalograph , Ltd. · CCJ · May 5, 1989 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K892524

## Device Facts

- **Applicant:** Vitalograph , Ltd.
- **Product Code:** [CCJ](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ.md)
- **Decision Date:** May 5, 1989
- **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/K892524](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K892524)

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