Clearance Summary
PregSense received FDA 510(k) clearance under submission number K191401, sponsored by Nuvo- Group , 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 2020-03-27.
- Submission: K191401
- Applicant / Sponsor: Nuvo- Group , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2730
- Decision date: 2020-03-27
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.