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FDA 510(k)

EzRay M (型号:VMX-P300)

K号: K203667 · 2021-02-02

决定日期2021-02-02
产品代码IZL
咨询委员会RA
决定实质等同

器械摘要

EzRay M (Model: VMX-P300) is the device name listed in this FDA 510(k) record. The listed applicant is VATECH Co., Ltd.. It received FDA 510(k) clearance on 2021-02-02 under 510(k) number K203667. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EzRay M (Model: VMX-P300)?

EzRay M (Model: VMX-P300) is a medical device that received FDA 510(k) clearance on 2021-02-02. The listed applicant is VATECH Co., Ltd.. The 510(k) number is K203667.

When did EzRay M (Model: VMX-P300) receive FDA 510(k) clearance?

EzRay M (Model: VMX-P300) received FDA 510(k) clearance on 2021-02-02, under 510(k) number K203667.

Who is the listed applicant for EzRay M (Model: VMX-P300)?

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

What is the FDA product code for EzRay M (Model: VMX-P300)?

The FDA product code for EzRay M (Model: VMX-P300) is IZL.

相关临床试验

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列明VATECH Co., Ltd.为申报人的其他记录

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相关器械(代码:IZL)

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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