Clearance Summary
AMIA AUTOMATED PD SYSTEM received FDA 510(k) clearance under submission number K124018, sponsored by Deka Research & Development Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2013-06-14.
- Submission: K124018
- Applicant / Sponsor: Deka Research & Development Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5630
- Decision date: 2013-06-14
Classification & Regulation
This clearance is catalogued under FDA product code FKX and 21 CFR 876.5630, within the Gastroenterology, Urology review panel as a Class II device.