K890624 is an FDA 510(k) clearance for the TISSUE OXYGEN MONITOR SYSTEM, MODEL II. This device is classified as a Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling (Class II - Special Controls, product code CCE).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on December 22, 1989, 318 days after receiving the submission on February 7, 1989.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1200.
| 510(k) Number | K890624 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 1989 |
| Decision Date | December 22, 1989 |
| Days to Decision | 318 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CCE — Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1200 |