BIO-C TEMP
K 號：K180199 · 2019-01-04
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器材摘要
BIO-C TEMP is the device name listed in this FDA 510(k) record. The listed applicant is Angelus Industria DE Produtos Odontologicos S/A. It received FDA 510(k) clearance on 2019-01-04 under 510(k) number K180199. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the BIO-C TEMP?
BIO-C TEMP is a medical device that received FDA 510(k) clearance on 2019-01-04. The listed applicant is Angelus Industria DE Produtos Odontologicos S/A. The 510(k) number is K180199.
When did BIO-C TEMP receive FDA 510(k) clearance?
BIO-C TEMP received FDA 510(k) clearance on 2019-01-04, under 510(k) number K180199.
Who is the listed applicant for BIO-C TEMP?
The FDA 510(k) record lists Angelus Industria DE Produtos Odontologicos S/A as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BIO-C TEMP?
The FDA product code for BIO-C TEMP is KIF.
其他以 Angelus Industria DE Produtos Odontologicos S/A 為申請人之記錄
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相關器械（代碼：KIF）
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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