510(k) K993008 ยท HGM System, Monitoring, Perinatal
QUANTITATIVE SENTINEL SYSTEM
| Applicant | Marquette Medical Systems, Inc., Annapolis MD, US |
| Decision | Substantially Equivalent, Dec 6, 1999 |
| Received | Sep 7, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993008
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2008 | GE Healthcare Integrated IT Solutions GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System - Alert and Reminder software; automatic patient data management providing clinical information at the bedside in Labor & Del Terminated |
HGM | None listed |
| Oct 15, 2008 | GE Healthcare Integrated IT Solutions Centricity Perinatal (formerly Quantitative Sentinel) System - Fluid Total Precision software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Moth Terminated |
HGM | None listed |
| Jul 30, 2008 | GE Healthcare Integrated IT Solutions GE Healthcare Centricity Perinatal (formerly QS) System - PFILS (Patient File Server) software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mot Terminated |
HGM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.