FDA 510(k)

EzRay M18（型號：VMX-P400）

K 號：K213462 · 2022-02-11

決定日期2022-02-11

產品代碼IZL

諮詢委員會RA

決定相當於

器材摘要

EzRay M18 (Model: VMX-P400) 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 2022-02-11 under 510(k) number K213462. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EzRay M18 (Model: VMX-P400)?

EzRay M18 (Model: VMX-P400) is a medical device that received FDA 510(k) clearance on 2022-02-11. The listed applicant is VATECH Co., Ltd.. The 510(k) number is K213462.

When did EzRay M18 (Model: VMX-P400) receive FDA 510(k) clearance?

EzRay M18 (Model: VMX-P400) received FDA 510(k) clearance on 2022-02-11, under 510(k) number K213462.

Who is the listed applicant for EzRay M18 (Model: VMX-P400)?

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 M18 (Model: VMX-P400)?

The FDA product code for EzRay M18 (Model: VMX-P400) is IZL.

其他以 VATECH Co., Ltd. 為申請人之記錄

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相關器械（代碼：IZL）

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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