FDA 510(k)

Nurochek系統

K 號：K200705 · 2020-04-23

決定日期2020-04-23

產品代碼GWE

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

Nurochek System is the device name listed in this FDA 510(k) record. The listed applicant is Cryptych Pty, Ltd.. It received FDA 510(k) clearance on 2020-04-23 under 510(k) number K200705. The device is classified under product code GWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Nurochek System?

Nurochek System is a medical device that received FDA 510(k) clearance on 2020-04-23. The listed applicant is Cryptych Pty, Ltd.. The 510(k) number is K200705.

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

Nurochek System received FDA 510(k) clearance on 2020-04-23, under 510(k) number K200705.

Who is the listed applicant for Nurochek System?

The FDA 510(k) record lists Cryptych Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nurochek System?

The FDA product code for Nurochek System is GWE.

其他以 Cryptych Pty, Ltd. 為申請人之記錄

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K160385精準螺絲

相關器械（代碼：GWE）

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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