FB-U Hemodialyzer
K-Number: K160444 · 2017-02-08
ApplicantNipro Medical Corporation
Decision Date2017-02-08
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
FB-U Hemodialyzer is a medical device manufactured by Nipro Medical Corporation. It received FDA 510(k) clearance on 2017-02-08 under approval number K160444. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FB-U Hemodialyzer?
FB-U Hemodialyzer is a medical device that received FDA 510(k) clearance on 2017-02-08. It is manufactured by Nipro Medical Corporation. The 510(k) number is K160444.
When was FB-U Hemodialyzer approved by the FDA?
FB-U Hemodialyzer received FDA 510(k) clearance on 2017-02-08, under approval number K160444.
What company makes FB-U Hemodialyzer?
FB-U Hemodialyzer is manufactured by Nipro Medical Corporation.
What is the FDA product code for FB-U Hemodialyzer?
The FDA product code for FB-U Hemodialyzer is KDI.
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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.