E-EEGX, N-EEGX
K 號：K191322 · 2020-01-22
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器材摘要
E-EEGX, N-EEGX is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare Finland Oy. It received FDA 510(k) clearance on 2020-01-22 under 510(k) number K191322. The device is classified under product code OLT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the E-EEGX, N-EEGX?
E-EEGX, N-EEGX is a medical device that received FDA 510(k) clearance on 2020-01-22. The listed applicant is GE Healthcare Finland Oy. The 510(k) number is K191322.
When did E-EEGX, N-EEGX receive FDA 510(k) clearance?
E-EEGX, N-EEGX received FDA 510(k) clearance on 2020-01-22, under 510(k) number K191322.
Who is the listed applicant for E-EEGX, N-EEGX?
FDA 510(k) 記錄將 GE Healthcare Finland Oy 列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for E-EEGX, N-EEGX?
The FDA product code for E-EEGX, N-EEGX is OLT.
其他以 GE Healthcare Finland Oy 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。
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相關器械（代碼：OLT）
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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