510(k) K010945 ยท DXH Transmitters And Receivers, Electrocardiograph, Telephone
HEARTCARD, MODEL 5258
| Applicant | Instromedix, San Diego CA, US |
| Decision | Substantially Equivalent, Jun 12, 2001 |
| Received | Mar 29, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010945
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.