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FDA 510(k)

Ez3D-i /E3

K-Number: K200178 · 2020-02-25

Decision Date2020-02-25
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ez3D-i /E3 is a medical device manufactured by Ewoosoft Co., Ltd.. It received FDA 510(k) clearance on 2020-02-25 under approval number K200178. 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-i /E3?

Ez3D-i /E3 is a medical device that received FDA 510(k) clearance on 2020-02-25. It is manufactured by Ewoosoft Co., Ltd.. The 510(k) number is K200178.

When was Ez3D-i /E3 approved by the FDA?

Ez3D-i /E3 received FDA 510(k) clearance on 2020-02-25, under approval number K200178.

What company makes Ez3D-i /E3?

Ez3D-i /E3 is manufactured by Ewoosoft Co., Ltd..

What is the FDA product code for Ez3D-i /E3?

The FDA product code for Ez3D-i /E3 is LLZ.

Other Devices by Ewoosoft Co., Ltd.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.