Clearance Summary
SONICAID FM820 AND FM830 ENCORE received FDA 510(k) clearance under submission number K090285, sponsored by Huntleigh Healthcare , Ltd.. 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 2009-07-15.
- Submission: K090285
- Applicant / Sponsor: Huntleigh Healthcare , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 2009-07-15
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.