The following data is part of a premarket notification filed by Koven And Assoc., Inc. with the FDA for Dvm-4200 Blood Flowmeter.
Device ID | K892707 |
510k Number | K892707 |
Device Name: | DVM-4200 BLOOD FLOWMETER |
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 | 1989-04-14 |
Decision Date | 1989-07-28 |