FDA 510(k)

E-CUBE 15

K-Number: K123610 · 2013-02-01

ApplicantAlpinion Medical Systems Co., Ltd.

Decision Date2013-02-01

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

E-CUBE 15 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 2013-02-01 under 510(k) number K123610. 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 15?

E-CUBE 15 is a medical device that received FDA 510(k) clearance on 2013-02-01. The listed applicant is Alpinion Medical Systems Co., Ltd.. The 510(k) number is K123610.

When did E-CUBE 15 receive FDA 510(k) clearance?

E-CUBE 15 received FDA 510(k) clearance on 2013-02-01, under 510(k) number K123610.

Who is the listed applicant for E-CUBE 15?

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 15?

The FDA product code for E-CUBE 15 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 K211299X-CUBE 70 K211300X-CUBE 90

View all 23 devices →

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.