Clearance Summary
COROMETRICS 815 FETAL ECG RECORDER received FDA 510(k) clearance under submission number K841477, sponsored by Ge Medical Systems Information Technologies. 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 1984-05-14.
- Submission: K841477
- Applicant / Sponsor: Ge Medical Systems Information Technologies
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 1984-05-14
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.