LumFuse-TP
K 號：K171630 · 2017-07-25
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器材摘要
LumFuse-TP is the device name listed in this FDA 510(k) record. The listed applicant is Precifit Medical, Ltd.. It received FDA 510(k) clearance on 2017-07-25 under 510(k) number K171630. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the LumFuse-TP?
LumFuse-TP is a medical device that received FDA 510(k) clearance on 2017-07-25. The listed applicant is Precifit Medical, Ltd.. The 510(k) number is K171630.
When did LumFuse-TP receive FDA 510(k) clearance?
LumFuse-TP received FDA 510(k) clearance on 2017-07-25, under 510(k) number K171630.
Who is the listed applicant for LumFuse-TP?
The FDA 510(k) record lists Precifit Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LumFuse-TP?
The FDA product code for LumFuse-TP is MAX.
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其他以 Precifit Medical, 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：MAX）
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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