Clearance Summary
BABY DOPPLEX 4000 (BD4000) received FDA 510(k) clearance under submission number K001677, sponsored by Huntleigh Diagnostics , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2000-08-14.
- Submission: K001677
- Applicant / Sponsor: Huntleigh Diagnostics , Ltd.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 2000-08-14
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.