510(k) K213974 ยท DPW Flowmeter, Blood, Cardiovascular
GEM FLOW COUPLER Monitor (GEM1020M-2)
| Applicant | Synovis Micro Companies Alliance, Inc., Birmingham AL, US |
| Decision | Substantially Equivalent, Apr 20, 2022 |
| Received | Dec 20, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K213974
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.