Clearance Summary
ABDOMINAL ECG PROCESSOR FOR FETAL MONI. received FDA 510(k) clearance under submission number K770295, 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: K770295
- Applicant / Sponsor: Brattle Instrument Corp.
- 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.