510(k) K231289 ยท DSH Recorder, Magnetic Tape, Medical
S-Patch Ex Wearable ECG Patch
| Applicant | Wellysis Corp., Seoul, KR |
| Decision | Substantially Equivalent, Aug 30, 2023 |
| Received | May 4, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231289
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.