FDA 510(k)

Nurochek-II 系統

K 號：K231914 · 2023-12-27

決定日期2023-12-27

產品代碼PIW

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-II System is the device name listed in this FDA 510(k) record. The listed applicant is Headsafe Mfg Pty, Ltd.. It received FDA 510(k) clearance on 2023-12-27 under 510(k) number K231914. The device is classified under product code PIW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Nurochek-II System?

Nurochek-II System is a medical device that received FDA 510(k) clearance on 2023-12-27. The listed applicant is Headsafe Mfg Pty, Ltd.. The 510(k) number is K231914.

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

Nurochek-II System received FDA 510(k) clearance on 2023-12-27, under 510(k) number K231914.

Who is the listed applicant for Nurochek-II System?

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

What is the FDA product code for Nurochek-II System?

The FDA product code for Nurochek-II System is PIW.

其他以 Headsafe Mfg Pty, Ltd. 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。

K243426Nurochek-Pro 系統

相關器械（代碼：PIW）

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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