The following data is part of a premarket notification filed by Koven Technology, Inc. with the FDA for Tubing Blood Flow Meter Model Number Hd-800.
| Device ID | K982986 |
| 510k Number | K982986 |
| Device Name: | TUBING BLOOD FLOW METER MODEL NUMBER HD-800 |
| Classification | Flowmeter, Blood, Cardiovascular |
| 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 | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-26 |
| Decision Date | 1998-11-24 |
| Summary: | summary |