FDA 510(k)

電腦化電腦皮層電位檢查設備

K 號：K212325 · 2022-06-15

決定日期2022-06-15

產品代碼GYB

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

EEG-acp is the device name listed in this FDA 510(k) record. The listed applicant is Somnomedics GmbH. It received FDA 510(k) clearance on 2022-06-15 under 510(k) number K212325. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EEG-acp?

EEG-acp is a medical device that received FDA 510(k) clearance on 2022-06-15. The listed applicant is Somnomedics GmbH. The 510(k) number is K212325.

When did EEG-acp receive FDA 510(k) clearance?

EEG-acp received FDA 510(k) clearance on 2022-06-15, under 510(k) number K212325.

Who is the listed applicant for EEG-acp?

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

What is the FDA product code for EEG-acp?

The FDA product code for EEG-acp is GYB.

其他以 Somnomedics GmbH 為申請人之記錄

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相關器械（代碼：GYB）

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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官方來源

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