K200337 is an FDA 510(k) clearance for the FloPatch (FP120). This device is classified as a Flowmeter, Blood, Cardiovascular (Class II - Special Controls, product code DPW).
Submitted by Flosonics Medical (R/A 1929803 Ontario Corp.) (Toronto, CA). The FDA issued a Cleared decision on March 24, 2020, 42 days after receiving the submission on February 11, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2100.
| 510(k) Number | K200337 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2020 |
| Decision Date | March 24, 2020 |
| Days to Decision | 42 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 |