FDA 510(k)

神經馬特三世

K 號：K181706 · 2018-07-26

決定日期2018-07-26

產品代碼HAW

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

neuromate Gen III is the device name listed in this FDA 510(k) record. The listed applicant is Renishaw Mayfield Sarl. It received FDA 510(k) clearance on 2018-07-26 under 510(k) number K181706. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the neuromate Gen III?

neuromate Gen III is a medical device that received FDA 510(k) clearance on 2018-07-26. The listed applicant is Renishaw Mayfield Sarl. The 510(k) number is K181706.

When did neuromate Gen III receive FDA 510(k) clearance?

neuromate Gen III received FDA 510(k) clearance on 2018-07-26, under 510(k) number K181706.

Who is the listed applicant for neuromate Gen III?

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

What is the FDA product code for neuromate Gen III?

The FDA product code for neuromate Gen III is HAW.

其他以 Renishaw Mayfield Sarl 為申請人之記錄

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K180206神經馬特三世

相關器械（代碼：HAW）

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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