510(k) K050583 ยท HGM System, Monitoring, Perinatal
MODEL 250 SERIES MATERNAL/FETAL MONITOR
| Applicant | Ge Medical Systems Information Technologies, Tampa FL, US |
| Decision | Substantially Equivalent, Jun 21, 2005 |
| Received | Mar 7, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050583
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.