The following data is part of a premarket notification filed by Koven Technology, Inc. with the FDA for Bidop 7.
| Device ID | K201114 |
| 510k Number | K201114 |
| Device Name: | Bidop 7 |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | Koven Technology, Inc. 477 N. Lindbergh Blvd., Ste.220 St. Louis, MO 63141 |
| Contact | Heather Bell |
| Correspondent | Harvey Knauss Delphi Consulting Group 11874 South Evelyn Circle Houston, TX 77071 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-27 |
| Decision Date | 2021-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00894912002982 | K201114 | 000 |
| 00894912002951 | K201114 | 000 |
| 00894912002821 | K201114 | 000 |
| 00894912002814 | K201114 | 000 |
| 00894912002784 | K201114 | 000 |
| 00894912002760 | K201114 | 000 |
| 00894912002753 | K201114 | 000 |
| 00894912002692 | K201114 | 000 |
| 00894912002159 | K201114 | 000 |