藍眼
K 號：K241591 · 2024-07-03
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器材摘要
Blue Eye is the device name listed in this FDA 510(k) record. The listed applicant is The Standard Co., Ltd.. It received FDA 510(k) clearance on 2024-07-03 under 510(k) number K241591. The device is classified under product code PLL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Blue Eye?
Blue Eye is a medical device that received FDA 510(k) clearance on 2024-07-03. The listed applicant is The Standard Co., Ltd.. The 510(k) number is K241591.
When did Blue Eye receive FDA 510(k) clearance?
Blue Eye received FDA 510(k) clearance on 2024-07-03, under 510(k) number K241591.
Who is the listed applicant for Blue Eye?
The FDA 510(k) record lists The Standard Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Blue Eye?
The FDA product code for Blue Eye is PLL.
其他以 The Standard 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。
相關器械（代碼：PLL）
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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