Clearance Summary
Sense4Baby System Model B+ (MSA) received FDA 510(k) clearance under submission number K143114, sponsored by Airstrip Technologies, 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 2015-03-10.
- Submission: K143114
- Applicant / Sponsor: Airstrip Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2730
- Decision date: 2015-03-10
Classification & Regulation
This clearance is catalogued under FDA product code LQK and 21 CFR 884.2730, within the Obstetrics/Gynecology review panel as a Class II device.