RightEye 適應性視覺系統
K 號：K181771 · 2018-09-28
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器材摘要
RightEye Vision System is the device name listed in this FDA 510(k) record. The listed applicant is Righteye, LLC. It received FDA 510(k) clearance on 2018-09-28 under 510(k) number K181771. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the RightEye Vision System?
RightEye Vision System is a medical device that received FDA 510(k) clearance on 2018-09-28. The listed applicant is Righteye, LLC. The 510(k) number is K181771.
When did RightEye Vision System receive FDA 510(k) clearance?
RightEye Vision System received FDA 510(k) clearance on 2018-09-28, under 510(k) number K181771.
Who is the listed applicant for RightEye Vision System?
The FDA 510(k) record lists Righteye, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RightEye Vision System?
The FDA product code for RightEye Vision System is GWN.
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相關器械（代碼：GWN）
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。
官方來源
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