PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30— 510(k) K052795
Substantially EquivalentPhilips Medizin Systeme Boeblingen GmbH
FDA 510(k) clearance K052795 for PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30, Substantially Equivalent on 2005-12-30. Applicant: Philips Medizin Systeme Boeblingen GmbH.
Clearance details
- Applicant
- Philips Medizin Systeme Boeblingen GmbH
- Product code
- Code HGM
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Boeblingen, Baden-Wuerttemberg, DE
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.