Clearance Summary
FM-1000 PLUS FETAL MONITOR received FDA 510(k) clearance under submission number K112187, sponsored by Advanced Instrumentations, 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 2011-09-21.
- Submission: K112187
- Applicant / Sponsor: Advanced Instrumentations, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 2011-09-21
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.