CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER
Device Facts
| Record ID | K893392 |
|---|---|
| Device Name | CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER |
| Applicant | Baxter Healthcare Corp |
| Product Code | DXG · Cardiovascular |
| Decision Date | Jun 20, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1435 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.
