FDA 510(k)

PaX-i3D 绿色高级（型号：PCT-90LH）

K号: K160882 · 2016-10-28

决定日期2016-10-28

产品代码OAS

咨询委员会RA

决定实质等同

器械摘要

PaX-i3D Green Premium (Model: PCT-90LH) 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 2016-10-28 under 510(k) number K160882. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PaX-i3D Green Premium (Model: PCT-90LH)?

PaX-i3D Green Premium (Model: PCT-90LH) is a medical device that received FDA 510(k) clearance on 2016-10-28. The listed applicant is VATECH Co., Ltd.. The 510(k) number is K160882.

When did PaX-i3D Green Premium (Model: PCT-90LH) receive FDA 510(k) clearance?

PaX-i3D Green Premium (Model: PCT-90LH) received FDA 510(k) clearance on 2016-10-28, under 510(k) number K160882.

Who is the listed applicant for PaX-i3D Green Premium (Model: PCT-90LH)?

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 PaX-i3D Green Premium (Model: PCT-90LH)?

The FDA product code for PaX-i3D Green Premium (Model: PCT-90LH) is OAS.

列明VATECH 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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官方来源

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