The following data is part of a premarket notification filed by Koven And Assoc., Inc. with the FDA for Es-1000sp Ii Smart Dop.
| Device ID | K903026 |
| 510k Number | K903026 |
| Device Name: | ES-1000SP II SMART DOP |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | KOVEN AND ASSOC., INC. THE TRADE CENTER 300 BROOKES DRIVE, SUITE 105 St. Louis, MO 63042 |
| Contact | Paul G Koven |
| Correspondent | Paul G 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 | 1990-07-10 |
| Decision Date | 1991-02-26 |