Clearance Summary
AQUANET, MODEL EC 2000 received FDA 510(k) clearance under submission number K000031, sponsored by Prime Pacific Health Innovations Corporation. 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 2001-09-10.
- Submission: K000031
- Applicant / Sponsor: Prime Pacific Health Innovations Corporation
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5220
- Decision date: 2001-09-10
Classification & Regulation
This clearance is catalogued under FDA product code KPL and 21 CFR 876.5220, within the Gastroenterology, Urology review panel as a Class II device.