E-CUBE 11
K-Number: K161439 · 2016-09-21
ApplicantAlpinion Medical Systems Co., Ltd.
Decision Date2016-09-21
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
E-CUBE 11 is a medical device manufactured by Alpinion Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2016-09-21 under approval number K161439. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the E-CUBE 11?
E-CUBE 11 is a medical device that received FDA 510(k) clearance on 2016-09-21. It is manufactured by Alpinion Medical Systems Co., Ltd.. The 510(k) number is K161439.
When was E-CUBE 11 approved by the FDA?
E-CUBE 11 received FDA 510(k) clearance on 2016-09-21, under approval number K161439.
What company makes E-CUBE 11?
E-CUBE 11 is manufactured by Alpinion Medical Systems Co., Ltd..
What is the FDA product code for E-CUBE 11?
The FDA product code for E-CUBE 11 is IYN.
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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.