← Product Code [CCK](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK) · K921526

# DATASCOPE PASSPORT MONITOR WITH CO2 (K921526)

_Datascope Corp. · CCK · Oct 14, 1992 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK/K921526

## Device Facts

- **Applicant:** Datascope Corp.
- **Product Code:** [CCK](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK.md)
- **Decision Date:** Oct 14, 1992
- **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/K921526](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK/K921526)

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