510(k) K243349 ยท DSI Detector And Alarm, Arrhythmia
BodyGuardian Remote Monitoring System (BGRMS v3.0)
| Applicant | Boston Scientific Cardiac Diagnostic Technologies, Inc., Rochester MN, US |
| Decision | Substantially Equivalent, Jan 23, 2026 |
| Received | Oct 28, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243349
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.