氟速
K 號：K191877 · 2019-08-05
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器材摘要
FLUOROspeed is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Corporation. It received FDA 510(k) clearance on 2019-08-05 under 510(k) number K191877. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the FLUOROspeed?
FLUOROspeed is a medical device that received FDA 510(k) clearance on 2019-08-05. The listed applicant is Shimadzu Corporation. The 510(k) number is K191877.
When did FLUOROspeed receive FDA 510(k) clearance?
FLUOROspeed received FDA 510(k) clearance on 2019-08-05, under 510(k) number K191877.
Who is the listed applicant for FLUOROspeed?
The FDA 510(k) record lists Shimadzu Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FLUOROspeed?
The FDA product code for FLUOROspeed is JAA.
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其他以 Shimadzu Corporation 為申請人之記錄
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相關器械（代碼：JAA）
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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