DORA Tubing Sets for Hemodialysis
K-Number: K161582 · 2017-06-16
Decision Date2017-06-16
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
DORA Tubing Sets for Hemodialysis is a medical device manufactured by Bain Medical Equipment (Guangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2017-06-16 under approval number K161582. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DORA Tubing Sets for Hemodialysis?
DORA Tubing Sets for Hemodialysis is a medical device that received FDA 510(k) clearance on 2017-06-16. It is manufactured by Bain Medical Equipment (Guangzhou) Co., Ltd.. The 510(k) number is K161582.
When was DORA Tubing Sets for Hemodialysis approved by the FDA?
DORA Tubing Sets for Hemodialysis received FDA 510(k) clearance on 2017-06-16, under approval number K161582.
What company makes DORA Tubing Sets for Hemodialysis?
DORA Tubing Sets for Hemodialysis is manufactured by Bain Medical Equipment (Guangzhou) Co., Ltd..
What is the FDA product code for DORA Tubing Sets for Hemodialysis?
The FDA product code for DORA Tubing Sets for Hemodialysis is FJK.
Other Devices by Bain Medical Equipment (Guangzhou) Co., Ltd.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.