Clearance Summary
TERUMO FETAL MONITOR # FHM-602 received FDA 510(k) clearance under submission number K801747, sponsored by Terumo Medical 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 1980-08-13.
- Submission: K801747
- Applicant / Sponsor: Terumo Medical Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 1980-08-13
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.