510(k) K200337 ยท DPW Flowmeter, Blood, Cardiovascular
FloPatch (FP120)
| Applicant | Flosonics Medical (R/A 1929803 Ontario Corp.), Toronto, CA |
| Decision | Substantially Equivalent, Mar 24, 2020 |
| Received | Feb 11, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200337
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2025 | Flosonics Medical (R/A 1929803 ONTARIO CORP.) FloPatch FP120, REF: FP120-FOT01-005 Open, Classified |
DPW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.