OC-Auto感測器 io iFOB測試
K 號：K191147 · 2020-01-02
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器材摘要
OC-Auto SENSOR io iFOB Test is the device name listed in this FDA 510(k) record. The listed applicant is Eiken Chemical Co., Ltd.. It received FDA 510(k) clearance on 2020-01-02 under 510(k) number K191147. The device is classified under product code OOX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the OC-Auto SENSOR io iFOB Test?
OC-Auto SENSOR io iFOB Test is a medical device that received FDA 510(k) clearance on 2020-01-02. The listed applicant is Eiken Chemical Co., Ltd.. The 510(k) number is K191147.
When did OC-Auto SENSOR io iFOB Test receive FDA 510(k) clearance?
OC-Auto SENSOR io iFOB Test received FDA 510(k) clearance on 2020-01-02, under 510(k) number K191147.
Who is the listed applicant for OC-Auto SENSOR io iFOB Test?
The FDA 510(k) record lists Eiken Chemical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OC-Auto SENSOR io iFOB Test?
The FDA product code for OC-Auto SENSOR io iFOB Test is OOX.
相關臨床試驗
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相關器械（代碼：OOX）
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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