510(k) K865032 ยท DSI Detector And Alarm, Arrhythmia
CARDIOFAX-V ECG-834OA
| Applicant | Nihon Kohden America, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Mar 10, 1987 |
| Received | Dec 23, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K865032
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.