510(k) K152491 ยท DSI Detector And Alarm, Arrhythmia
MoMe Software Platform
| Applicant | Infobionic, Inc., Lowell MA, US |
| Decision | Substantially Equivalent, Dec 17, 2015 |
| Received | Sep 1, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152491
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.