510(k) K193104 ยท DSI Detector And Alarm, Arrhythmia
Unified Arrhythmia Diagnostic System PocketECG IV
| Applicant | Medicalgorithmics S.A., Warsaw, PL |
| Decision | Substantially Equivalent, Apr 9, 2020 |
| Received | Nov 8, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K193104
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.