FDA 510(k)

數位神經港生物電位信號處理系統

K 號：K202174 · 2021-02-10

決定日期2021-02-10

產品代碼GWL

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

Digital NeuroPort Biopotential Signal Processing System is the device name listed in this FDA 510(k) record. The listed applicant is Blackrock Microsystems. It received FDA 510(k) clearance on 2021-02-10 under 510(k) number K202174. 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 Digital NeuroPort Biopotential Signal Processing System?

Digital NeuroPort Biopotential Signal Processing System is a medical device that received FDA 510(k) clearance on 2021-02-10. The listed applicant is Blackrock Microsystems. The 510(k) number is K202174.

When did Digital NeuroPort Biopotential Signal Processing System receive FDA 510(k) clearance?

Digital NeuroPort Biopotential Signal Processing System received FDA 510(k) clearance on 2021-02-10, under 510(k) number K202174.

Who is the listed applicant for Digital NeuroPort Biopotential Signal Processing System?

The FDA 510(k) record lists Blackrock Microsystems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital NeuroPort Biopotential Signal Processing System?

The FDA product code for Digital NeuroPort Biopotential Signal Processing System is GWL.

其他以 Blackrock Microsystems 為申請人之記錄

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K191346Blackrock神經CoG硬膜下皮層電極（條狀和網格）

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。

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官方來源

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