Rover
K 號：K201488 · 2020-07-17
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器材摘要
Rover is the device name listed in this FDA 510(k) record. The listed applicant is Micro-X , Ltd.. It received FDA 510(k) clearance on 2020-07-17 under 510(k) number K201488. 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 Rover?
Rover is a medical device that received FDA 510(k) clearance on 2020-07-17. The listed applicant is Micro-X , Ltd.. The 510(k) number is K201488.
When did Rover receive FDA 510(k) clearance?
Rover received FDA 510(k) clearance on 2020-07-17, under 510(k) number K201488.
Who is the listed applicant for Rover?
The FDA 510(k) record lists Micro-X , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Rover?
The FDA product code for Rover is IZL.
相關臨床試驗
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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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官方來源
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