Comby 脑電圖帽
K 號：K211315 · 2021-11-09
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器材摘要
Comby EEG Caps is the device name listed in this FDA 510(k) record. The listed applicant is Pamel D.O.O. It received FDA 510(k) clearance on 2021-11-09 under 510(k) number K211315. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Comby EEG Caps?
Comby EEG Caps is a medical device that received FDA 510(k) clearance on 2021-11-09. The listed applicant is Pamel D.O.O. The 510(k) number is K211315.
When did Comby EEG Caps receive FDA 510(k) clearance?
Comby EEG Caps received FDA 510(k) clearance on 2021-11-09, under 510(k) number K211315.
Who is the listed applicant for Comby EEG Caps?
The FDA 510(k) record lists Pamel D.O.O as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Comby EEG Caps?
The FDA product code for Comby EEG Caps is GXY.
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相關器械（代碼：GXY）
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
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