510(k) K140847 ยท MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
CARDIOSPY ECG HOLTER SYSTEMS
| Applicant | Labtech Kft., Debrecen, HU |
| Decision | Substantially Equivalent, Dec 5, 2014 |
| Received | Apr 3, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140847
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.