510(k) K261580 ยท MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
ZBPro Diagnostic (Version 2.0)
| Applicant | Zbeats, Inc., Stony Brook NY, US |
| Decision | Substantially Equivalent, Sep 11, 2026 |
| Received | May 13, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261580
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.