Clearance Summary
FETAL ASSIST received FDA 510(k) clearance under submission number K002548, 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 2001-03-06.
- Submission: K002548
- Applicant / Sponsor: Huntleigh Diagnostics , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 2001-03-06
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.