Clearance Summary
DORA Tubing Sets for Hemodialysis received FDA 510(k) clearance under submission number K161582, sponsored by Bain Medical Equipment (Guangzhou) Co., Ltd.. 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 2017-06-16.
- Submission: K161582
- Applicant / Sponsor: Bain Medical Equipment (Guangzhou) Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 2017-06-16
Classification & Regulation
This clearance is catalogued under FDA product code FJK and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.