Clearance Summary
SENSE-4BABY SYSTEM received FDA 510(k) clearance under submission number K132918, sponsored by Sense4baby , Inc.. 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 2013-11-22.
- Submission: K132918
- Applicant / Sponsor: Sense4baby , Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 2013-11-22
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.