FDA 510(k)

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K 號：K222032 · 2022-10-26

決定日期2022-10-26

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

NEUROMARK System is the device name listed in this FDA 510(k) record. The listed applicant is Neurent Medical. It received FDA 510(k) clearance on 2022-10-26 under 510(k) number K222032. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NEUROMARK System?

NEUROMARK System is a medical device that received FDA 510(k) clearance on 2022-10-26. The listed applicant is Neurent Medical. The 510(k) number is K222032.

When did NEUROMARK System receive FDA 510(k) clearance?

NEUROMARK System received FDA 510(k) clearance on 2022-10-26, under 510(k) number K222032.

Who is the listed applicant for NEUROMARK System?

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

What is the FDA product code for NEUROMARK System?

The FDA product code for NEUROMARK System is GEI.

其他以 Neurent Medical 為申請人之記錄

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K212666神經市場系統

相關器械（代碼：GEI）

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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