Clearance Summary
MODIFICATION FETAL MONITOR MODEL FM-2 received FDA 510(k) clearance under submission number K852518, sponsored by Advantage Medical Systems, Inc.. 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 1985-07-05.
- Submission: K852518
- Applicant / Sponsor: Advantage Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 1985-07-05
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.