← Product Code [CCK](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK) · K861398

# PRE-CHECK C02 DETECTOR (K861398)

_Alleghany Intl. Medical Technology · CCK · May 6, 1986 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK/K861398

## Device Facts

- **Applicant:** Alleghany Intl. Medical Technology
- **Product Code:** [CCK](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK.md)
- **Decision Date:** May 6, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.1400
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK/K861398](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK/K861398)

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