← Product Code [CCK](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK) · K894053

# 2ND MODIFICATION OF FEF(TM) END-TIDAL CO2 DETECTOR (K894053)

_Fenem, Inc. · CCK · Jul 20, 1989 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK/K894053

## Device Facts

- **Applicant:** Fenem, Inc.
- **Product Code:** [CCK](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK.md)
- **Decision Date:** Jul 20, 1989
- **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/K894053](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK/K894053)

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