The following data is part of a premarket notification filed by Koven Technology, Inc. with the FDA for Fast Sphyg By Koven.
| Device ID | K143332 |
| 510k Number | K143332 |
| Device Name: | Fast Sphyg By Koven |
| Classification | Blood Pressure Cuff |
| Applicant | KOVEN TECHNOLOGY, INC. 12125 WOODCREST EXECUTIVE DR. SUITE 320 St. Louis, MO 63141 |
| Contact | Heather Bell |
| Correspondent | Heather Bell KOVEN TECHNOLOGY, INC. 12125 WOODCREST EXECUTIVE DR. SUITE 320 St. Louis, MO 63141 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-20 |
| Decision Date | 2015-04-14 |
| Summary: | summary |