Clearance Summary
PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50 received FDA 510(k) clearance under submission number K092028, sponsored by Philips Medizin Systeme Boeblingen GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2010-02-17.
- Submission: K092028
- Applicant / Sponsor: Philips Medizin Systeme Boeblingen GmbH
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 2010-02-17
Classification & Regulation
This clearance is catalogued under FDA product code HGM and 21 CFR 884.2740, within the Obstetrics/Gynecology review panel as a Class II device.