Clearance Summary
MONITOR, FETAL, NO. L04-1100 received FDA 510(k) clearance under submission number K770692, 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 1977-04-26.
- Submission: K770692
- Applicant / Sponsor: Brattle Instrument Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 1977-04-26
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.