FDA 510(k)

E-CUBE i7

K-Number: K182594 · 2019-01-24

ApplicantAlpinion Medical Systems Co., Ltd.

Decision Date2019-01-24

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

E-CUBE i7 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 2019-01-24 under 510(k) number K182594. 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 i7?

E-CUBE i7 is a medical device that received FDA 510(k) clearance on 2019-01-24. The listed applicant is Alpinion Medical Systems Co., Ltd.. The 510(k) number is K182594.

When did E-CUBE i7 receive FDA 510(k) clearance?

E-CUBE i7 received FDA 510(k) clearance on 2019-01-24, under 510(k) number K182594.

Who is the listed applicant for E-CUBE i7?

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 i7?

The FDA product code for E-CUBE i7 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.