K885296 is an FDA 510(k) clearance for the MINIFLOW DISPOSABLE PRESSURE TRANSDUCER 63-600F. This device is classified as a Transducer, Blood-pressure, Extravascular (Class II - Special Controls, product code DRS).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on January 25, 1989, 29 days after receiving the submission on December 27, 1988.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2850.
| 510(k) Number | K885296 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 1988 |
| Decision Date | January 25, 1989 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DRS — Transducer, Blood-pressure, Extravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2850 |