RetinAI 發現
K 號：K211715 · 2022-04-28
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器材摘要
RetinAI Discovery is the device name listed in this FDA 510(k) record. The listed applicant is Retinai Medical AG. It received FDA 510(k) clearance on 2022-04-28 under 510(k) number K211715. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the RetinAI Discovery?
RetinAI Discovery is a medical device that received FDA 510(k) clearance on 2022-04-28. The listed applicant is Retinai Medical AG. The 510(k) number is K211715.
When did RetinAI Discovery receive FDA 510(k) clearance?
RetinAI Discovery received FDA 510(k) clearance on 2022-04-28, under 510(k) number K211715.
Who is the listed applicant for RetinAI Discovery?
The FDA 510(k) record lists Retinai Medical AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RetinAI Discovery?
The FDA product code for RetinAI Discovery is NFJ.
相關臨床試驗
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相關器械（代碼：NFJ）
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
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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