510(k) K111083 ยท HGM System, Monitoring, Perinatal
PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50
| Applicant | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, Boeblingen, Baden-Wuerttemberg, DE |
| Decision | Substantially Equivalent, Aug 17, 2011 |
| Received | Apr 19, 2011 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K111083
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2014 | Philips Medical Systems, Inc. Philips Avalon Monitors with software revision J.30.58:
Model Product
FM20 M2702A ;
FM30 M2703A ;
FM50 M2705A
Intended for: " Monitoring the physiological parameters of pregnant women " Non-inv Terminated |
HGM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.