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FDA 510(k)

Amydi-med 一次性非侵入式電極

K 號：K240668 · 2024-03-19

申請人Shenzhen Amydi-Med Electrics Tech Co., Ltd.
決定日期2024-03-19
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

Amydi-med Disposable Non-invasive EEG electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Amydi-Med Electrics Tech Co., Ltd.. It received FDA 510(k) clearance on 2024-03-19 under 510(k) number K240668. 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 Amydi-med Disposable Non-invasive EEG electrodes?

Amydi-med Disposable Non-invasive EEG electrodes is a medical device that received FDA 510(k) clearance on 2024-03-19. The listed applicant is Shenzhen Amydi-Med Electrics Tech Co., Ltd.. The 510(k) number is K240668.

When did Amydi-med Disposable Non-invasive EEG electrodes receive FDA 510(k) clearance?

Amydi-med Disposable Non-invasive EEG electrodes received FDA 510(k) clearance on 2024-03-19, under 510(k) number K240668.

Who is the listed applicant for Amydi-med Disposable Non-invasive EEG electrodes?

The FDA 510(k) record lists Shenzhen Amydi-Med Electrics Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Amydi-med Disposable Non-invasive EEG electrodes?

The FDA product code for Amydi-med Disposable Non-invasive EEG electrodes is GXY.

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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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