8-CH 脑電圖放大器
K 號：K201747 · 2020-12-27
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器材摘要
8-CH Electroencephalography Amplifier is the device name listed in this FDA 510(k) record. The listed applicant is Hipposcreen Neurotech Corp.. It received FDA 510(k) clearance on 2020-12-27 under 510(k) number K201747. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the 8-CH Electroencephalography Amplifier?
8-CH Electroencephalography Amplifier is a medical device that received FDA 510(k) clearance on 2020-12-27. The listed applicant is Hipposcreen Neurotech Corp.. The 510(k) number is K201747.
When did 8-CH Electroencephalography Amplifier receive FDA 510(k) clearance?
8-CH Electroencephalography Amplifier received FDA 510(k) clearance on 2020-12-27, under 510(k) number K201747.
Who is the listed applicant for 8-CH Electroencephalography Amplifier?
The FDA 510(k) record lists Hipposcreen Neurotech Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 8-CH Electroencephalography Amplifier?
The FDA product code for 8-CH Electroencephalography Amplifier is GWL.
相關臨床試驗
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相關器械（代碼：GWL）
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
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