510(k) K121197 ยท DSI Detector And Alarm, Arrhythmia
BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT
| Applicant | Preventice, Inc., Rochester MN, US |
| Decision | Substantially Equivalent, Aug 10, 2012 |
| Received | Apr 19, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121197
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.