510(k) K990068 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
SOLAR 9500 INFORMATION MONITOR
| Applicant | General Electric Medical Systems Information Techn, Milwaukee WI, US |
| Decision | Substantially Equivalent, Jul 14, 1999 |
| Received | Jan 8, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990068
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2018 | GE Healthcare, LLC Solar 9500 Information 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.