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FDA 510(k)

E-CUBE

K-Number: K111616 · 2011-08-19

ApplicantSaeshin Precision Co., Ltd.
Decision Date2011-08-19
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

E-CUBE is the device name listed in this FDA 510(k) record. The listed applicant is Saeshin Precision Co., Ltd.. It received FDA 510(k) clearance on 2011-08-19 under 510(k) number K111616. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E-CUBE?

E-CUBE is a medical device that received FDA 510(k) clearance on 2011-08-19. The listed applicant is Saeshin Precision Co., Ltd.. The 510(k) number is K111616.

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

E-CUBE received FDA 510(k) clearance on 2011-08-19, under 510(k) number K111616.

Who is the listed applicant for E-CUBE?

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

What is the FDA product code for E-CUBE?

The FDA product code for E-CUBE is EKX.

Other records listing Saeshin Precision Co., Ltd. as applicant

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Related Devices (Code: EKX)

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.

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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.

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