FDA 510(k)

nordicBrainEx

K 號：K163324 · 2017-01-27

決定日期2017-01-27

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

nordicBrainEx is the device name listed in this FDA 510(k) record. The listed applicant is Nordicneurolab AS. It received FDA 510(k) clearance on 2017-01-27 under 510(k) number K163324. 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 nordicBrainEx?

nordicBrainEx is a medical device that received FDA 510(k) clearance on 2017-01-27. The listed applicant is Nordicneurolab AS. The 510(k) number is K163324.

When did nordicBrainEx receive FDA 510(k) clearance?

nordicBrainEx received FDA 510(k) clearance on 2017-01-27, under 510(k) number K163324.

Who is the listed applicant for nordicBrainEx?

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

What is the FDA product code for nordicBrainEx?

The FDA product code for nordicBrainEx is LLZ.

其他以 Nordicneurolab AS 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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