The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Phoenix Disposable Pressure Transducer #73-600.
| Device ID | K925638 |
| 510k Number | K925638 |
| Device Name: | PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600 |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Contact | Ponzoa Parker |
| Correspondent | Ponzoa Parker BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Product Code | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-09 |
| Decision Date | 1993-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889942169795 | K925638 | 000 |
| 10888277089938 | K925638 | 000 |
| 40888277804129 | K925638 | 000 |