NovaLine Tubing Sets for Hemodialysis
K-Number: K201866 · 2021-03-10
Decision Date2021-03-10
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
NovaLine Tubing Sets for Hemodialysis is a medical device manufactured by Bain Medical Equipment (Guangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2021-03-10 under approval number K201866. 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 NovaLine Tubing Sets for Hemodialysis?
NovaLine Tubing Sets for Hemodialysis is a medical device that received FDA 510(k) clearance on 2021-03-10. It is manufactured by Bain Medical Equipment (Guangzhou) Co., Ltd.. The 510(k) number is K201866.
When was NovaLine Tubing Sets for Hemodialysis approved by the FDA?
NovaLine Tubing Sets for Hemodialysis received FDA 510(k) clearance on 2021-03-10, under approval number K201866.
What company makes NovaLine Tubing Sets for Hemodialysis?
NovaLine Tubing Sets for Hemodialysis is manufactured by Bain Medical Equipment (Guangzhou) Co., Ltd..
What is the FDA product code for NovaLine Tubing Sets for Hemodialysis?
The FDA product code for NovaLine 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.