FDA 510(k)

ROSA ONE 腦部應用程序

K 號：K182417 · 2019-02-07

決定日期2019-02-07

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

ROSA ONE Brain Application is the device name listed in this FDA 510(k) record. The listed applicant is Medtech S.A. It received FDA 510(k) clearance on 2019-02-07 under 510(k) number K182417. 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 ROSA ONE Brain Application?

ROSA ONE Brain Application is a medical device that received FDA 510(k) clearance on 2019-02-07. The listed applicant is Medtech S.A. The 510(k) number is K182417.

When did ROSA ONE Brain Application receive FDA 510(k) clearance?

ROSA ONE Brain Application received FDA 510(k) clearance on 2019-02-07, under 510(k) number K182417.

Who is the listed applicant for ROSA ONE Brain Application?

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

What is the FDA product code for ROSA ONE Brain Application?

The FDA product code for ROSA ONE Brain Application is HAW.

其他以 Medtech S.A 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。

K200511ROSA ONE 腦部應用程序 K192173ROSA ONE脊椎應用 K182848ROSA ONE脊椎應用 K172444ROSA腦（v3.0.0.5）K151511ROSA脊椎

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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官方來源

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