The following data is part of a premarket notification filed by Koven Technology, Inc. with the FDA for Pw Doppler Vascular Probes.
| Device ID | K935994 |
| 510k Number | K935994 |
| Device Name: | PW DOPPLER VASCULAR PROBES |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | KOVEN TECHNOLOGY, INC. 300 BROOKES DR. SUITE 105 St. Louis, MO 63042 |
| Contact | Paul G Koven |
| Correspondent | Paul G Koven KOVEN TECHNOLOGY, INC. 300 BROOKES DR. SUITE 105 St. Louis, MO 63042 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-15 |
| Decision Date | 1995-05-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00894912002647 | K935994 | 000 |
| 00894912002739 | K935994 | 000 |
| 00894912002722 | K935994 | 000 |
| 00894912002661 | K935994 | 000 |
| 00894912002654 | K935994 | 000 |
| 00894912002579 | K935994 | 000 |
| 00894912002562 | K935994 | 000 |
| 00894912002494 | K935994 | 000 |
| 00894912002869 | K935994 | 000 |
| 00894912002548 | K935994 | 000 |
| 00894912002746 | K935994 | 000 |
| 00894912002944 | K935994 | 000 |
| 00894912002630 | K935994 | 000 |
| 00894912002623 | K935994 | 000 |
| 00894912002616 | K935994 | 000 |
| 00894912002609 | K935994 | 000 |
| 00894912002593 | K935994 | 000 |
| 00894912002586 | K935994 | 000 |
| 00894912002524 | K935994 | 000 |
| 00894912002517 | K935994 | 000 |
| 00894912002500 | K935994 | 000 |
| 00894912002531 | K935994 | 000 |