510(k) K252839 ยท MWJ Electrocardiograph, Ambulatory (Without Analysis)
ZywieZ3 Sensor & Adhesive
| Applicant | Zywie, Inc., Johns Creek GA, US |
| Decision | Substantially Equivalent, Jun 18, 2026 |
| Received | Sep 5, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252839
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.