510(k) K233394 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Gem Flow Now (GEM2770-FN)
| Applicant | Synovis Micro Companies Alliance, Birmingham AL, US |
| Decision | Substantially Equivalent, Jan 28, 2024 |
| Received | Oct 3, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233394
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.