510(k) K151188 ยท DSI Detector And Alarm, Arrhythmia
BodyGuardian Remote Monitoring System
| Applicant | Preventice, Rochester MN, US |
| Decision | Substantially Equivalent, Sep 17, 2015 |
| Received | May 4, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151188
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2019 | Preventice Services, LLC BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Models BC-1001-A or BC1001-D, and a cell phone, either Models BP1008 or BP10014, that is paired to both of the mon Terminated |
DSI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.