510(k) K010396 ยท MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
C. NET 2100
| Applicant | Cardionetics, Ltd., Waltham MA, US |
| Decision | Substantially Equivalent, Oct 4, 2001 |
| Received | Feb 9, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010396
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.