510(k) K112601 ยท MWJ Electrocardiograph, Ambulatory (Without Analysis)
INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER
| Applicant | Intricon Datrix Corporation, Appollo Beach FL, US |
| Decision | Substantially Equivalent, Nov 9, 2011 |
| Received | Sep 7, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112601
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.