Clearance Summary
FETAL MONITOR, PART #100-11009 received FDA 510(k) clearance under submission number K770297, sponsored by Brattle Instrument 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 1977-03-09.
- Submission: K770297
- Applicant / Sponsor: Brattle Instrument Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 1977-03-09
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.