FDA 510(k)

MaxxiGold 電極 48，MaxxiGold 電極 60，MaxxiGold 電極 96

K 號：K163547 · 2017-04-11

決定日期2017-04-11

產品代碼GXY

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

MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 is the device name listed in this FDA 510(k) record. The listed applicant is Neurovirtual USA, Inc.. It received FDA 510(k) clearance on 2017-04-11 under 510(k) number K163547. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96?

MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 is a medical device that received FDA 510(k) clearance on 2017-04-11. The listed applicant is Neurovirtual USA, Inc.. The 510(k) number is K163547.

When did MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 receive FDA 510(k) clearance?

MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 received FDA 510(k) clearance on 2017-04-11, under 510(k) number K163547.

Who is the listed applicant for MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96?

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

What is the FDA product code for MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96?

The FDA product code for MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 is GXY.

其他以 Neurovirtual USA, Inc. 為申請人之記錄

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相關器械（代碼：GXY）

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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