MAGENTIQ-COLO (ME-APDS)
K 號：K252178 · 2025-10-03
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器材摘要
MAGENTIQ-COLO (ME-APDS) is the device name listed in this FDA 510(k) record. The listed applicant is Magentiq Eye, Ltd.. It received FDA 510(k) clearance on 2025-10-03 under 510(k) number K252178. The device is classified under product code QNP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the MAGENTIQ-COLO (ME-APDS)?
MAGENTIQ-COLO (ME-APDS) is a medical device that received FDA 510(k) clearance on 2025-10-03. The listed applicant is Magentiq Eye, Ltd.. The 510(k) number is K252178.
When did MAGENTIQ-COLO (ME-APDS) receive FDA 510(k) clearance?
MAGENTIQ-COLO (ME-APDS) received FDA 510(k) clearance on 2025-10-03, under 510(k) number K252178.
Who is the listed applicant for MAGENTIQ-COLO (ME-APDS)?
The FDA 510(k) record lists Magentiq Eye, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MAGENTIQ-COLO (ME-APDS)?
The FDA product code for MAGENTIQ-COLO (ME-APDS) is QNP.
相關臨床試驗
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其他以 Magentiq Eye, 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：QNP）
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
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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