Clearance Summary
FETALGARD 3000 FETAL MONITOR received FDA 510(k) clearance under submission number K983395, sponsored by Analogic Corp.. 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 1999-08-12.
- Submission: K983395
- Applicant / Sponsor: Analogic Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 1999-08-12
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.