510(k) K062088 ยท MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
PREMIER 11 HOLTER
| Applicant | Diagnostic Monitoring Software, Stateline NV, US |
| Decision | Substantially Equivalent, Aug 25, 2006 |
| Received | Jul 24, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K062088
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.