FDA 510(k)

EzRay Air 2 Wall（型號：VEX-S350W）

K 號：K223058 · 2022-10-26

決定日期2022-10-26

產品代碼EHD

諮詢委員會DE

決定相當於

器材摘要

EzRay Air 2 Wall (Model: VEX-S350W) 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 2022-10-26 under 510(k) number K223058. 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 2 Wall (Model: VEX-S350W)?

EzRay Air 2 Wall (Model: VEX-S350W) is a medical device that received FDA 510(k) clearance on 2022-10-26. The listed applicant is VATECH Co., Ltd.. The 510(k) number is K223058.

When did EzRay Air 2 Wall (Model: VEX-S350W) receive FDA 510(k) clearance?

EzRay Air 2 Wall (Model: VEX-S350W) received FDA 510(k) clearance on 2022-10-26, under 510(k) number K223058.

Who is the listed applicant for EzRay Air 2 Wall (Model: VEX-S350W)?

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 2 Wall (Model: VEX-S350W)?

The FDA product code for EzRay Air 2 Wall (Model: VEX-S350W) 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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