EzRay M (型號：VMX-P300)
K 號：K203667 · 2021-02-02
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器材摘要
EzRay M (Model: VMX-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 2021-02-02 under 510(k) number K203667. 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 M (Model: VMX-P300)?
EzRay M (Model: VMX-P300) is a medical device that received FDA 510(k) clearance on 2021-02-02. The listed applicant is VATECH Co., Ltd.. The 510(k) number is K203667.
When did EzRay M (Model: VMX-P300) receive FDA 510(k) clearance?
EzRay M (Model: VMX-P300) received FDA 510(k) clearance on 2021-02-02, under 510(k) number K203667.
Who is the listed applicant for EzRay M (Model: VMX-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 M (Model: VMX-P300)?
The FDA product code for EzRay M (Model: VMX-P300) is IZL.
相關臨床試驗
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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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官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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