510(k) K841084 ยท DSI Detector And Alarm, Arrhythmia
ARRHYTHMIA SYSTEM AC-11
| Applicant | Fukuda Denshi USA, Inc., Kirkland WA, US |
| Decision | Substantially Equivalent, Feb 1, 1985 |
| Received | Mar 13, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K841084
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.