氟羅卡爾
K 號：K182917 · 2019-11-18
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器材摘要
FluoroCal is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2019-11-18 under 510(k) number K182917. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the FluoroCal?
FluoroCal is a medical device that received FDA 510(k) clearance on 2019-11-18. The listed applicant is Bisco, Inc.. The 510(k) number is K182917.
When did FluoroCal receive FDA 510(k) clearance?
FluoroCal received FDA 510(k) clearance on 2019-11-18, under 510(k) number K182917.
Who is the listed applicant for FluoroCal?
The FDA 510(k) record lists Bisco, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FluoroCal?
The FDA product code for FluoroCal is LBH.
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其他以 Bisco, Inc. 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：LBH）
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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