510(k) K963904 ยท DXH Transmitters And Receivers, Electrocardiograph, Telephone
P.H.D. - PERSONAL HEART DEVICE MODEL 5258
| Applicant | Heart Alert, Inc., Douglasville GA, US |
| Decision | Substantially Equivalent, May 15, 1997 |
| Received | Sep 30, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963904
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.