Clearance Summary
PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50 received FDA 510(k) clearance under submission number K111083, sponsored by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2011-08-17.
- Submission: K111083
- Applicant / Sponsor: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 2011-08-17
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.