The following data is part of a premarket notification filed by Koven Technology, Inc. with the FDA for Bidirectional Doppler W/waveform Display.
| Device ID | K954397 |
| 510k Number | K954397 |
| Device Name: | BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY |
| Classification | Flowmeter, Blood, Cardiovascular |
| 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 | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-20 |
| Decision Date | 1996-03-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00894912002043 | K954397 | 000 |