FROG (玻璃過濾移除)
K 號：K240355 · 2025-04-18
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決定日期2025-04-18
產品代碼FMI
諮詢委員會醫療設備規範文本翻譯如下：
HO
注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於
器材摘要
FROG (Filter Removal of Glass) is the device name listed in this FDA 510(k) record. The listed applicant is Carrtech Corp. It received FDA 510(k) clearance on 2025-04-18 under 510(k) number K240355. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the FROG (Filter Removal of Glass)?
FROG (Filter Removal of Glass) is a medical device that received FDA 510(k) clearance on 2025-04-18. The listed applicant is Carrtech Corp. The 510(k) number is K240355.
When did FROG (Filter Removal of Glass) receive FDA 510(k) clearance?
FROG (Filter Removal of Glass) received FDA 510(k) clearance on 2025-04-18, under 510(k) number K240355.
Who is the listed applicant for FROG (Filter Removal of Glass)?
The FDA 510(k) record lists Carrtech Corp as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FROG (Filter Removal of Glass)?
The FDA product code for FROG (Filter Removal of Glass) is FMI.
相關臨床試驗
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：FMI）
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
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