FDA 510(k)

iCE-SG 皮下单極電極陣列

K 號：K201678 · 2021-03-08

決定日期2021-03-08

產品代碼GZL

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

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.

常見問題

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.

其他以 Ice Neurosystems, Inc. 為申請人之記錄

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K222706iCE-SG2 皮下单極電極組合套件 K191868iCEWav神經監測平台

相關器械（代碼：GZL）

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。

官方來源

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