510(k) K830306 ยท DSI Detector And Alarm, Arrhythmia
HEARTRATE PLUS ECG CARDULE #1918
| Applicant | Spacelabs, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 17, 1983 |
| Received | Jan 31, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K830306
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.