510(k) K973141 ยท DXH Transmitters And Receivers, Electrocardiograph, Telephone
HEART ACCESS PLUS CARDIAC EVENT RECORDER
| Applicant | Paceart, Inc., Hasbrouck Heights NJ, US |
| Decision | Substantially Equivalent, Nov 12, 1997 |
| Received | Aug 21, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973141
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.