510(k) K140535 ยท HGM System, Monitoring, Perinatal
PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50
| Applicant | Philips Medizin Systeme Boblingen GmbH, Boeblingen, DE |
| Decision | Substantially Equivalent, Nov 25, 2014 |
| Received | Mar 4, 2014 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K140535
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 22, 2026 | Philips North America Llc Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A Open, Classified |
HGM | None listed |
| Jun 22, 2026 | Philips North America Llc Philips Avalon Fetal Monitor, FM 30 Part numberM2703A Open, Classified |
HGM | None listed |
| Jun 28, 2024 | Philips North America Llc Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate. Open, Classified |
HGM | None listed |
| Sep 19, 2019 | Pacific Medical Group Inc. Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250 Open, Classified |
HGM | None listed |
| Sep 19, 2019 | Pacific Medical Group Inc. Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250 Open, Classified |
HGM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.