E-CUBE 12
K-Number: K181277 · 2018-09-28
ApplicantAlpinion Medical Systems Co., Ltd.
Decision Date2018-09-28
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
E-CUBE 12 is a medical device manufactured by Alpinion Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2018-09-28 under approval number K181277. 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 12?
E-CUBE 12 is a medical device that received FDA 510(k) clearance on 2018-09-28. It is manufactured by Alpinion Medical Systems Co., Ltd.. The 510(k) number is K181277.
When was E-CUBE 12 approved by the FDA?
E-CUBE 12 received FDA 510(k) clearance on 2018-09-28, under approval number K181277.
What company makes E-CUBE 12?
E-CUBE 12 is manufactured by Alpinion Medical Systems Co., Ltd..
What is the FDA product code for E-CUBE 12?
The FDA product code for E-CUBE 12 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.