K201114 is an FDA 510(k) clearance for the Bidop 7. This device is classified as a Flowmeter, Blood, Cardiovascular (Class II - Special Controls, product code DPW).
Submitted by Koven Technology, Inc. (St. Louis, US). The FDA issued a Cleared decision on January 5, 2021, 253 days after receiving the submission on April 27, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2100.
| 510(k) Number | K201114 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2020 |
| Decision Date | January 05, 2021 |
| Days to Decision | 253 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPW - Flowmeter, Blood, Cardiovascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2100 |