K893392 is an FDA 510(k) clearance for the CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER. This device is classified as a Computer, Diagnostic, Pre-programmed, Single-function (Class II - Special Controls, product code DXG).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on June 20, 1989, 50 days after receiving the submission on May 1, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1435.
| 510(k) Number | K893392 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 1989 |
| Decision Date | June 20, 1989 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DXG — Computer, Diagnostic, Pre-programmed, Single-function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1435 |