510(k) K001359 ยท DSI Detector And Alarm, Arrhythmia
DASH 3000/4000 PATIENT MONITOR
| Applicant | General Electric Medical Systems Information Techn, Milwaukee WI, US |
| Decision | Substantially Equivalent, Jul 18, 2000 |
| Received | Apr 28, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001359
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2018 | GE Healthcare, LLC Dash 4000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients. Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.