FDA 510(k)

Green16/Green18（型號：PHT-65LHS）

K 號：K170066 · 2017-06-16

決定日期2017-06-16

產品代碼OAS

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

其他以 VATECH Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：OAS）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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