FDA 510(k)

EzRay Air 軻便式（型號：VEX-P300）

K 號：K200182 · 2020-02-11

決定日期2020-02-11

產品代碼EHD

諮詢委員會DE

決定相當於

器材摘要

EzRay Air Portable (Model: VEX-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 2020-02-11 under 510(k) number K200182. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EzRay Air Portable (Model: VEX-P300)?

EzRay Air Portable (Model: VEX-P300) is a medical device that received FDA 510(k) clearance on 2020-02-11. The listed applicant is VATECH Co., Ltd.. The 510(k) number is K200182.

When did EzRay Air Portable (Model: VEX-P300) receive FDA 510(k) clearance?

EzRay Air Portable (Model: VEX-P300) received FDA 510(k) clearance on 2020-02-11, under 510(k) number K200182.

Who is the listed applicant for EzRay Air Portable (Model: VEX-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 Air Portable (Model: VEX-P300)?

The FDA product code for EzRay Air Portable (Model: VEX-P300) is EHD.

其他以 VATECH Co., Ltd. 為申請人之記錄

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相關器械（代碼：EHD）

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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