510(k) K002068 ยท DSI Detector And Alarm, Arrhythmia
ORG-9200A
| Applicant | Nihon Kohden America, Inc., Foothill CA, US |
| Decision | Substantially Equivalent, Feb 8, 2001 |
| Received | Jul 7, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002068
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.