The following data is part of a premarket notification filed by Koven Technology, Inc. with the FDA for V-link 3.2 For Windows.
Device ID | K963274 |
510k Number | K963274 |
Device Name: | V-LINK 3.2 FOR WINDOWS |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
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 | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-08-20 |
Decision Date | 1996-10-31 |