Clearance Summary
MODIFIED FETAL MONITOR MODEL FM-2 received FDA 510(k) clearance under submission number K861556, 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 1986-07-07.
- Submission: K861556
- 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: 1986-07-07
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.