FDA 510(k)

神經量測儀

K 號：K170981 · 2017-09-07

決定日期2017-09-07

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

NeuroQuant is the device name listed in this FDA 510(k) record. The listed applicant is Cortechs Labs, Inc.. It received FDA 510(k) clearance on 2017-09-07 under 510(k) number K170981. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NeuroQuant?

NeuroQuant is a medical device that received FDA 510(k) clearance on 2017-09-07. The listed applicant is Cortechs Labs, Inc.. The 510(k) number is K170981.

When did NeuroQuant receive FDA 510(k) clearance?

NeuroQuant received FDA 510(k) clearance on 2017-09-07, under 510(k) number K170981.

Who is the listed applicant for NeuroQuant?

FDA 510(k) 記錄將 Cortechs Labs, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for NeuroQuant?

The FDA product code for NeuroQuant is LLZ.

其他以 Cortechs Labs, Inc. 為申請人之記錄

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相關器械（代碼：LLZ）

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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