Clearance Summary
FETASONDE FETAL HEART RATE VARIABILITY received FDA 510(k) clearance under submission number K791039, sponsored by Roche Medical Electronics, 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 1979-09-04.
- Submission: K791039
- Applicant / Sponsor: Roche Medical Electronics, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 1979-09-04
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.