PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50— 510(k) K111083

Substantially Equivalent

Philips Medizinsysteme Boeblingen GmbH, Cardiac AN

FDA 510(k) clearance K111083 for PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50, Substantially Equivalent on 2011-08-17. Applicant: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN.

Clearance details

Applicant: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 2011-04-19
Decision date: 2011-08-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Boeblingen, Baden-Wuerttemberg, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code HGM

product code HGM

Death: 35
Malfunction: 478
Total: 513

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.