510(k) K203638 ยท DSH Recorder, Magnetic Tape, Medical
AT-Patch ECG Analysis System
| Applicant | Atsens Co., Ltd., Seongnam-Si, KR |
| Decision | Substantially Equivalent, Oct 12, 2022 |
| Received | Dec 14, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203638
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.