510(k) K193177 ยท MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
CER-S
| Applicant | Cardiocalm, Montichiari, IT |
| Decision | Substantially Equivalent, Aug 26, 2020 |
| Received | Nov 18, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193177
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.