510(k) K001634 ยท DXH Transmitters And Receivers, Electrocardiograph, Telephone
CARDIOSENTRY EVENT MONITOR, MODEL 8470-01
| Applicant | Tz Medical, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Dec 21, 2000 |
| Received | May 26, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001634
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.