Clearance Summary
HANDYDOP received FDA 510(k) clearance under submission number K030466, sponsored by Elcat, GmbH. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2003-09-12.
- Submission: K030466
- Applicant / Sponsor: Elcat, GmbH
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2660
- Decision date: 2003-09-12
Classification & Regulation
This clearance is catalogued under FDA product code KNG and 21 CFR 884.2660, within the Obstetrics/Gynecology review panel as a Class II device.