FDA 510(k)

EzRay Air W

K 號：K163705 · 2017-01-24

決定日期2017-01-24

產品代碼EHD

諮詢委員會DE

決定相當於

器材摘要

EzRay Air W 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 2017-01-24 under 510(k) number K163705. 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 W?

EzRay Air W is a medical device that received FDA 510(k) clearance on 2017-01-24. The listed applicant is VATECH Co., Ltd.. The 510(k) number is K163705.

When did EzRay Air W receive FDA 510(k) clearance?

EzRay Air W received FDA 510(k) clearance on 2017-01-24, under 510(k) number K163705.

Who is the listed applicant for EzRay Air W?

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 W?

The FDA product code for EzRay Air W 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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