Fusion Bx 2.0
K 號：K181290 · 2018-06-15
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器材摘要
Fusion Bx 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Focal Healthcare, Inc.. It received FDA 510(k) clearance on 2018-06-15 under 510(k) number K181290. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Fusion Bx 2.0?
Fusion Bx 2.0 is a medical device that received FDA 510(k) clearance on 2018-06-15. The listed applicant is Focal Healthcare, Inc.. The 510(k) number is K181290.
When did Fusion Bx 2.0 receive FDA 510(k) clearance?
Fusion Bx 2.0 received FDA 510(k) clearance on 2018-06-15, under 510(k) number K181290.
Who is the listed applicant for Fusion Bx 2.0?
The FDA 510(k) record lists Focal Healthcare, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Fusion Bx 2.0?
The FDA product code for Fusion Bx 2.0 is LLZ.
相關臨床試驗
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相關器械（代碼：LLZ）
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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