Clearance Summary
Sonicaid Team3 received FDA 510(k) clearance under submission number K250777, sponsored by Huntleigh Healthcare , 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 2025-09-19.
- Submission: K250777
- Applicant / Sponsor: Huntleigh Healthcare , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 2025-09-19
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.