FDA 510(k)

恩博生物無線電腦電極圖（EEG）

K 號：K162681 · 2017-06-02

決定日期2017-06-02

產品代碼GWQ

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Enobio Wireless EEG is the device name listed in this FDA 510(k) record. The listed applicant is Neuroelectrics Barcelona S.L.U.. It received FDA 510(k) clearance on 2017-06-02 under 510(k) number K162681. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Enobio Wireless EEG?

Enobio Wireless EEG is a medical device that received FDA 510(k) clearance on 2017-06-02. The listed applicant is Neuroelectrics Barcelona S.L.U.. The 510(k) number is K162681.

When did Enobio Wireless EEG receive FDA 510(k) clearance?

Enobio Wireless EEG received FDA 510(k) clearance on 2017-06-02, under 510(k) number K162681.

Who is the listed applicant for Enobio Wireless EEG?

The FDA 510(k) record lists Neuroelectrics Barcelona S.L.U. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Enobio Wireless EEG?

The FDA product code for Enobio Wireless EEG is GWQ.

其他以 Neuroelectrics Barcelona S.L.U. 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。

K261604Enobio Dx (Enobio Dx 8)；Enobio Dx (Enobio Dx 20)；Enobio Dx (Enobio Dx 32)

相關器械（代碼：GWQ）

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。

K261604Enobio Dx (Enobio Dx 8)；Enobio Dx (Enobio Dx 20)；Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455新波系統Zeto, Inc.K233403Flexset 系統Zeto, Inc.K231366神經航行者 PlusBioserenity Sas K221959Q21 Q21 (請提供完整的原文，以便進行翻譯。)Neurofield, Inc.K231457SPARK 扫描器Spark Neuro, Inc.

官方來源

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