LF900 医療設備規範文本翻譯： LF900 医療設備規範文本
K 號：K231437 · 2023-07-19
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器材摘要
LF900 is the device name listed in this FDA 510(k) record. The listed applicant is Daesung Maref Co., Ltd.. It received FDA 510(k) clearance on 2023-07-19 under 510(k) number K231437. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the LF900?
LF900 is a medical device that received FDA 510(k) clearance on 2023-07-19. The listed applicant is Daesung Maref Co., Ltd.. The 510(k) number is K231437.
When did LF900 receive FDA 510(k) clearance?
LF900 received FDA 510(k) clearance on 2023-07-19, under 510(k) number K231437.
Who is the listed applicant for LF900?
The FDA 510(k) record lists Daesung Maref Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LF900?
The FDA product code for LF900 is IRP.
其他以 Daesung Maref Co., Ltd. 為申請人之記錄
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相關器械（代碼：IRP）
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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