510(k) K062137 ยท HGM System, Monitoring, Perinatal
MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30
| Applicant | Philips Medizin Systeme Boeblingen GmbH, Boeblingen, Baden-Wuerttemberg, DE |
| Decision | Substantially Equivalent, Aug 24, 2006 |
| Received | Jul 26, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K062137
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2009 | Philips Healthcare Inc. Philips Avalon Fetal Monitor FM 20
Catalog Number: M2702A. Terminated |
HGM | None listed |
| Dec 17, 2009 | Philips Healthcare Inc. Philips Avalon Fetal Monitor FM 30
Catalog Number: M2703A. Terminated |
HGM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.