HEWLETT-PACKARD MODEL M1016A CO2 & M1017A FI02
Device Facts
| Record ID | K896030 |
|---|---|
| Device Name | HEWLETT-PACKARD MODEL M1016A CO2 & M1017A FI02 |
| Applicant | Hewlett-Packard Co. |
| Product Code | CCK · Anesthesiology |
| Decision Date | Dec 22, 1989 |
| 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.
