FUKUDA DENSHI MODEL HC-300 END TIDAL CO2 MODULE
Device Facts
| Record ID | K950044 |
|---|---|
| Device Name | FUKUDA DENSHI MODEL HC-300 END TIDAL CO2 MODULE |
| Applicant | Fukuda Denshi USA, Inc. |
| Product Code | CCK · Anesthesiology |
| Decision Date | Sep 15, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.1400 |
| Device Class | Class 2 |
Regulatory Classification
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.
