Clearance Summary
CERNER FETALINK+(VERSION1.0) received FDA 510(k) clearance under submission number K121758, sponsored by Cerner 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 2012-10-09.
- Submission: K121758
- Applicant / Sponsor: Cerner Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 2012-10-09
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.