510(k) K012467 ยท DSI Detector And Alarm, Arrhythmia
SOLAR 8000M SYSTEM
| Applicant | General Electric Medical Systems Information Techn, Milwaukee WI, US |
| Decision | Substantially Equivalent, Feb 11, 2002 |
| Received | Aug 1, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012467
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2018 | GE Healthcare, LLC Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients. Open, Classified |
MHX | None listed |
| Jan 5, 2009 | GE Healthcare GE Healthcare Solar 8000M System, a multiparameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients, within a hospital or facility environment Terminated |
DSI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.