Clearance Summary
MODIFICATION TO FETAL ASSIST received FDA 510(k) clearance under submission number K020390, sponsored by Huntleigh Diagnostics , 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 2002-04-19.
- Submission: K020390
- Applicant / Sponsor: Huntleigh Diagnostics , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2730
- Decision date: 2002-04-19
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.