藍色 400
K 號：K211346 · 2022-07-22
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器材摘要
BLUE 400 is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2022-07-22 under 510(k) number K211346. The device is classified under product code QFX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the BLUE 400?
BLUE 400 is a medical device that received FDA 510(k) clearance on 2022-07-22. The listed applicant is Carl Zeiss Meditec, AG. The 510(k) number is K211346.
When did BLUE 400 receive FDA 510(k) clearance?
BLUE 400 received FDA 510(k) clearance on 2022-07-22, under 510(k) number K211346.
Who is the listed applicant for BLUE 400?
FDA 510(k) 記錄將 Carl Zeiss Meditec, AG 列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for BLUE 400?
The FDA product code for BLUE 400 is QFX.
其他以 Carl Zeiss Meditec, AG 為申請人之記錄
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相關器械（代碼：QFX）
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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