K191388 is an FDA 510(k) clearance for the FloPatch (FP110). 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.) (Sudbury, CA). The FDA issued a Cleared decision on June 21, 2019, 28 days after receiving the submission on May 24, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2100.
| 510(k) Number | K191388 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 2019 |
| Decision Date | June 21, 2019 |
| Days to Decision | 28 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 |