510(k) K161582
K161582 is an FDA 510(k) premarket notification submitted by Bain Medical Equipment (Guangzhou) Co., Ltd. for the device "DORA Tubing Sets for Hemodialysis". The FDA issued a decision of Substantially Equivalent on June 16, 2017. The device falls under product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve), a Class II device regulated under 21 CFR 876.5820. Bain Medical Equipment (Guangzhou) Co., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 16, 2017
- Date Received
- June 8, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type