PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50— 510(k) K140535
Substantially EquivalentPhilips Medizin Systeme Boblingen GmbH
FDA 510(k) clearance K140535 for PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50, Substantially Equivalent on 2014-11-25. Applicant: Philips Medizin Systeme Boblingen GmbH. Device class: 2.
Clearance details
- Applicant
- Philips Medizin Systeme Boblingen GmbH
- Product code
- Code HGM
- Device class
- Class 2
- Regulation
- 21 CFR 884.2740
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Boeblingen, DE
Recent devices under product code HGM
view allMore clearances from Philips Medizin Systeme Boblingen GmbH
view allAdverse events under product code HGM
product code HGM- Death
- 35
- Malfunction
- 478
- Total
- 513
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K140535
K-number listed on FDA's recall record- Z-2522-2026 — Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
- Z-2523-2026 — Philips Avalon Fetal Monitor, FM 30 Part numberM2703A
- Z-2239-2024 — Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.
- Z-0984-2020 — Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250
- Z-0985-2020 — Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140535.
Data sourced from openFDA. This site is unofficial and independent of the FDA.