510(k) K954163 ยท DXH Transmitters And Receivers, Electrocardiograph, Telephone
RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER
| Applicant | Cardiac Evaluation Center, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Jul 11, 1996 |
| Received | Sep 5, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954163
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.