FDA 510(k)

数字耳镜与儿童中耳炎教育和反馈的比较

K号: K202174 · 2021-02-10

决定日期2021-02-10

产品代码GWL

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决定实质等同

器械摘要

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.

常见问题

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.

列明Blackrock Microsystems为申报人的其他记录

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K191346Blackrock NeuroCoG 颅下皮质电极（条带和网格）

官方来源

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