FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Alpinion Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2018-09-28 under 510(k) 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. The listed applicant is Alpinion Medical Systems Co., Ltd.. The 510(k) number is K181277.

When did E-CUBE 12 receive FDA 510(k) clearance?

E-CUBE 12 received FDA 510(k) clearance on 2018-09-28, under 510(k) number K181277.

Who is the listed applicant for E-CUBE 12?

The FDA 510(k) record lists Alpinion Medical Systems Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E-CUBE 12?

The FDA product code for E-CUBE 12 is IYN.

Other records listing Alpinion Medical Systems Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223564X-CUBE 50, X-CUBE 60 K221093X-CUBE 70, X-CUBE 90 K220857X-CUBE 50, X-CUBE 60 K213523X-CUBE i8, X-CUBE i9 K211300X-CUBE 90 K211299X-CUBE 70

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Related Devices (Code: IYN)

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.