Clearance Summary
COROMETRICS MODEL 171 AND 172 FETAL MONITOR received FDA 510(k) clearance under submission number K991905, sponsored by General Electric Medical Systems Information Techn. 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 1999-09-01.
- Submission: K991905
- Applicant / Sponsor: General Electric Medical Systems Information Techn
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 1999-09-01
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.