510(k) K083535 ยท DXH Transmitters And Receivers, Electrocardiograph, Telephone
HEARTRAK SMART ECAT
| Applicant | Universal Medical, Inc., Ewing NJ, US |
| Decision | Substantially Equivalent, Dec 15, 2008 |
| Received | Nov 28, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083535
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.