FDA 510(k)

Green Smart (Model: PHT-35LHS)

K号: K162660 · 2016-10-20

决定日期2016-10-20

产品代码OAS

咨询委员会RA

决定实质等同

器械摘要

Green Smart (Model: PHT-35LHS) 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 2016-10-20 under 510(k) number K162660. 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 Green Smart (Model: PHT-35LHS)?

Green Smart (Model: PHT-35LHS) is a medical device that received FDA 510(k) clearance on 2016-10-20. The listed applicant is VATECH Co., Ltd.. The 510(k) number is K162660.

When did Green Smart (Model: PHT-35LHS) receive FDA 510(k) clearance?

Green Smart (Model: PHT-35LHS) received FDA 510(k) clearance on 2016-10-20, under 510(k) number K162660.

Who is the listed applicant for Green Smart (Model: PHT-35LHS)?

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 Green Smart (Model: PHT-35LHS)?

The FDA product code for Green Smart (Model: PHT-35LHS) 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。

K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)K243088Green X 12 SE (PHT-40CHS)K243081Green X 21 (PHT-90CHO)K240040VistaPano S Ceph 2.0（VistaPano S Ceph）；VistaPano S 2.0（VistaPano S）；ProVecta S-Pan Ceph 2.0（ProVecta S-Pan Ceph）；ProVecta S-Pan 2.0（ProVecta S-Pan）K231796Grreen X 12（型号：PHT-75CHS）K223058EzRay Air 2 Wall (型号：VEX-S350W)

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官方来源

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