Clearance Summary
MODEL 2120IS SERIES MATERNAL/FETAL MONITOR received FDA 510(k) clearance under submission number K021135, sponsored by Ge Medical Systems Information Technologies. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2002-05-09.
- Submission: K021135
- Applicant / Sponsor: Ge Medical Systems Information Technologies
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 2002-05-09
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.