The following data is part of a premarket notification filed by Koven Technology, Inc. with the FDA for Smartdop 45 Vascular Doppler.
| Device ID | K050601 |
| 510k Number | K050601 |
| Device Name: | SMARTDOP 45 VASCULAR DOPPLER |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | KOVEN TECHNOLOGY, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 -3404 |
| Contact | J. Harvey Knauss |
| Correspondent | J. Harvey Knauss KOVEN TECHNOLOGY, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 -3404 |
| Product Code | DPW |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-09 |
| Decision Date | 2005-04-15 |
| Summary: | summary |