FDA 510(k)

NICO 大腦通路

K 號：K172433 · 2017-09-07

決定日期2017-09-07

產品代碼GZT

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

NICO BrainPath is the device name listed in this FDA 510(k) record. The listed applicant is Nico Corporation. It received FDA 510(k) clearance on 2017-09-07 under 510(k) number K172433. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NICO BrainPath?

NICO BrainPath is a medical device that received FDA 510(k) clearance on 2017-09-07. The listed applicant is Nico Corporation. The 510(k) number is K172433.

When did NICO BrainPath receive FDA 510(k) clearance?

NICO BrainPath received FDA 510(k) clearance on 2017-09-07, under 510(k) number K172433.

Who is the listed applicant for NICO BrainPath?

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

What is the FDA product code for NICO BrainPath?

The FDA product code for NICO BrainPath is GZT.

其他以 Nico Corporation 為申請人之記錄

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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相關器械（代碼：GZT）

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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