FDA 510(k)

WaveGuard Net 脑電圖帽 (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)

K 號：K240575 · 2024-11-25

申請人Eemagine Medical Imaging Solutions GmbH

決定日期2024-11-25

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

WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) is the device name listed in this FDA 510(k) record. The listed applicant is Eemagine Medical Imaging Solutions GmbH. It received FDA 510(k) clearance on 2024-11-25 under 510(k) number K240575. 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 WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)?

WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) is a medical device that received FDA 510(k) clearance on 2024-11-25. The listed applicant is Eemagine Medical Imaging Solutions GmbH. The 510(k) number is K240575.

When did WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) receive FDA 510(k) clearance?

WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) received FDA 510(k) clearance on 2024-11-25, under 510(k) number K240575.

Who is the listed applicant for WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)?

The FDA 510(k) record lists Eemagine Medical Imaging Solutions GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)?

The FDA product code for WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) is GXY.

其他以 Eemagine Medical Imaging Solutions GmbH 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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