510(k) K993788 ยท MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
R.TEST EVOLUTION
| Applicant | Novacor Div., Flemington NJ, US |
| Decision | Substantially Equivalent, Aug 4, 2000 |
| Received | Nov 9, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993788
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.