K925638 is an FDA 510(k) clearance for the PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600. This device is classified as a Transducer, Pressure, Catheter Tip (Class II - Special Controls, product code DXO).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on October 18, 1993, 343 days after receiving the submission on November 9, 1992.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2870.
| 510(k) Number | K925638 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 1992 |
| Decision Date | October 18, 1993 |
| Days to Decision | 343 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DXO — Transducer, Pressure, Catheter Tip |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2870 |