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FDA 510(k)

Ez3D Plus

K-Number: K152746 · 2016-01-03

ApplicantEwoosoft Co., Ltd.
Decision Date2016-01-03
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ez3D Plus is the device name listed in this FDA 510(k) record. The listed applicant is Ewoosoft Co., Ltd.. It received FDA 510(k) clearance on 2016-01-03 under 510(k) number K152746. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ez3D Plus?

Ez3D Plus is a medical device that received FDA 510(k) clearance on 2016-01-03. The listed applicant is Ewoosoft Co., Ltd.. The 510(k) number is K152746.

When did Ez3D Plus receive FDA 510(k) clearance?

Ez3D Plus received FDA 510(k) clearance on 2016-01-03, under 510(k) number K152746.

Who is the listed applicant for Ez3D Plus?

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

What is the FDA product code for Ez3D Plus?

The FDA product code for Ez3D Plus is LLZ.

Other records listing Ewoosoft Co., Ltd. as applicant

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Related Devices (Code: LLZ)

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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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