510(k) K252389 · DSH Recorder, Magnetic Tape, Medical
Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)
| Applicant | Smwmed, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Apr 23, 2026 |
| Received | Jul 31, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252389
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.