Clearance Summary
MONITOR, FETAL HEART, MODEL 1980 received FDA 510(k) clearance under submission number K770292, sponsored by Berkeley Bio-Engineering. 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 1977-03-09.
- Submission: K770292
- Applicant / Sponsor: Berkeley Bio-Engineering
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4120
- Decision date: 1977-03-09
Classification & Regulation
This clearance is catalogued under FDA product code HGI and 21 CFR 884.4120, within the Obstetrics/Gynecology review panel as a Class II device.