510(k) K182030 ยท MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Faros Mobile
| Applicant | Bittium Biosignals , Ltd., Kuopio, FI |
| Decision | Substantially Equivalent, Nov 8, 2018 |
| Received | Jul 30, 2018 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K182030
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.