Clearance Summary
ELPHA 4 CONTI received FDA 510(k) clearance under submission number K032988, sponsored by Danmeter A/S. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2003-12-03.
- Submission: K032988
- Applicant / Sponsor: Danmeter A/S
- Clearance pathway: Abbreviated
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5320
- Decision date: 2003-12-03
Classification & Regulation
This clearance is catalogued under FDA product code KPI and 21 CFR 876.5320, within the Gastroenterology, Urology review panel as a Class II device.