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FDA 510(k)

雲端功能神經生理學平台

K 號:K221963 · 2023-04-27

決定日期2023-04-27
產品代碼GWQ
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

Cumulus Functional Neurophysiology Platform is the device name listed in this FDA 510(k) record. The listed applicant is Cumulus Neuroscience Limited. It received FDA 510(k) clearance on 2023-04-27 under 510(k) number K221963. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cumulus Functional Neurophysiology Platform?

Cumulus Functional Neurophysiology Platform is a medical device that received FDA 510(k) clearance on 2023-04-27. The listed applicant is Cumulus Neuroscience Limited. The 510(k) number is K221963.

When did Cumulus Functional Neurophysiology Platform receive FDA 510(k) clearance?

Cumulus Functional Neurophysiology Platform received FDA 510(k) clearance on 2023-04-27, under 510(k) number K221963.

Who is the listed applicant for Cumulus Functional Neurophysiology Platform?

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

What is the FDA product code for Cumulus Functional Neurophysiology Platform?

The FDA product code for Cumulus Functional Neurophysiology Platform is GWQ.

相關臨床試驗

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相關器械(代碼:GWQ)

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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