510(k) K233864 ยท MWJ Electrocardiograph, Ambulatory (Without Analysis)
ASSURE Wearable ECG
| Applicant | Kestra Medical Technologies, Inc., Kirkland WA, US |
| Decision | Substantially Equivalent, May 7, 2024 |
| Received | Dec 6, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233864
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.