510(k) K030575 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
MODIFICATION TO SOLAR 9500 INFORMATION MONITOR
| Applicant | Ge Medical Systems Information Technologies, Milwaukee WI, US |
| Decision | Substantially Equivalent, Mar 21, 2003 |
| Received | Feb 24, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K030575
| 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 |
| Dec 18, 2003 | General Electric Medical Systems Information Technology Solar 9500 Information Monitor with software version 3A. Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.