FDA 510(k)

Green16/Green18 (Model: PHT-65LHS)

K号: K170066 · 2017-06-16

决定日期2017-06-16

产品代码OAS

咨询委员会RA

决定实质等同

器械摘要

Green16/Green18 (Model: PHT-65LHS) 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 2017-06-16 under 510(k) number K170066. 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 Green16/Green18 (Model: PHT-65LHS)?

Green16/Green18 (Model: PHT-65LHS) is a medical device that received FDA 510(k) clearance on 2017-06-16. The listed applicant is VATECH Co., Ltd.. The 510(k) number is K170066.

When did Green16/Green18 (Model: PHT-65LHS) receive FDA 510(k) clearance?

Green16/Green18 (Model: PHT-65LHS) received FDA 510(k) clearance on 2017-06-16, under 510(k) number K170066.

Who is the listed applicant for Green16/Green18 (Model: PHT-65LHS)?

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 Green16/Green18 (Model: PHT-65LHS)?

The FDA product code for Green16/Green18 (Model: PHT-65LHS) 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)

查看所有 18 个设备 →

官方来源

在 FDA 数据库中查看 →

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。