510(k) K895806 ยท DSI Detector And Alarm, Arrhythmia
ELATEC HOLTER ANALYZER
| Applicant | Ela Medical, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Apr 4, 1990 |
| Received | Sep 28, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895806
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.