510(k) K021135 ยท HGM System, Monitoring, Perinatal
MODEL 2120IS SERIES MATERNAL/FETAL MONITOR
| Applicant | Ge Medical Systems Information Technologies, Wallingford CT, US |
| Decision | Substantially Equivalent, May 9, 2002 |
| Received | Apr 9, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021135
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 23, 2003 | GE Medical Systems Information Technologies GE Medical Systems COROMETRICS Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is Terminated |
HGM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.