The following data is part of a premarket notification filed by Koven And Assoc., Inc. with the FDA for Smartdop 20 Bi-directional Blood Flow Detector.
| Device ID | K920333 |
| 510k Number | K920333 |
| Device Name: | SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | KOVEN AND ASSOC., INC. THE TRADE CENTER 300 BROOKES DRIVE, SUITE 105 St. Louis, MO 63042 |
| Contact | Paul Koven |
| Correspondent | Paul Koven KOVEN AND ASSOC., INC. THE TRADE CENTER 300 BROOKES DRIVE, 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 | 1992-01-27 |
| Decision Date | 1993-01-22 |