Clearance Summary
CIV-OB (PLUS) received FDA 510(k) clearance under submission number K103172, sponsored by Civnet Communication, Ltd.. 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 2011-03-11.
- Submission: K103172
- Applicant / Sponsor: Civnet Communication, Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 2011-03-11
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.