FDA 510(k)

iCE-SG 皮下电极阵列

K号: K201678 · 2021-03-08

决定日期2021-03-08

产品代码GZL

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决定实质等同

器械摘要

iCE-SG Subcutaneous Electrode Arrays is the device name listed in this FDA 510(k) record. The listed applicant is Ice Neurosystems, Inc.. It received FDA 510(k) clearance on 2021-03-08 under 510(k) number K201678. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the iCE-SG Subcutaneous Electrode Arrays?

iCE-SG Subcutaneous Electrode Arrays is a medical device that received FDA 510(k) clearance on 2021-03-08. The listed applicant is Ice Neurosystems, Inc.. The 510(k) number is K201678.

When did iCE-SG Subcutaneous Electrode Arrays receive FDA 510(k) clearance?

iCE-SG Subcutaneous Electrode Arrays received FDA 510(k) clearance on 2021-03-08, under 510(k) number K201678.

Who is the listed applicant for iCE-SG Subcutaneous Electrode Arrays?

The FDA 510(k) record lists Ice Neurosystems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iCE-SG Subcutaneous Electrode Arrays?

The FDA product code for iCE-SG Subcutaneous Electrode Arrays is GZL.

列明Ice Neurosystems, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K222706iCE-SG2 皮下电极套件 K191868iCEWav 神经监护平台

相关器械（代码：GZL）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

官方来源

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