510(k) K962970 ยท DSI Detector And Alarm, Arrhythmia
SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION
| Applicant | Spacelabs Medical, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Mar 25, 1997 |
| Received | Jul 31, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962970
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.