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FDA 510(k)

Ez3D-i /E3

K号: K231757 · 2023-07-14

决定日期2023-07-14
产品代码QIH
咨询委员会RA
决定实质等同

器械摘要

Ez3D-i /E3 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 2023-07-14 under 510(k) number K231757. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ez3D-i /E3?

Ez3D-i /E3 is a medical device that received FDA 510(k) clearance on 2023-07-14. The listed applicant is Ewoosoft Co., Ltd.. The 510(k) number is K231757.

When did Ez3D-i /E3 receive FDA 510(k) clearance?

Ez3D-i /E3 received FDA 510(k) clearance on 2023-07-14, under 510(k) number K231757.

Who is the listed applicant for Ez3D-i /E3?

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-i /E3?

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

列明Ewoosoft Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系;请查阅链接的官方来源。

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相关器械(代码:QIH)

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系;请查阅链接的官方来源。

官方来源

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数据来源于FDA开放API。如需最新且权威的信息,请务必参考官方记录。

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