510(k) K013046 ยท DSI Detector And Alarm, Arrhythmia
COSMOS SYSTEM
| Applicant | Spacelabs Medical, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Aug 21, 2002 |
| Received | Sep 10, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013046
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.