FDA 510(k)

XACT機器人系統

K 號：K191332 · 2019-10-03

決定日期2019-10-03

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

XACT Robotic System is the device name listed in this FDA 510(k) record. The listed applicant is Xact Robotics, Ltd.. It received FDA 510(k) clearance on 2019-10-03 under 510(k) number K191332. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the XACT Robotic System?

XACT Robotic System is a medical device that received FDA 510(k) clearance on 2019-10-03. The listed applicant is Xact Robotics, Ltd.. The 510(k) number is K191332.

When did XACT Robotic System receive FDA 510(k) clearance?

XACT Robotic System received FDA 510(k) clearance on 2019-10-03, under 510(k) number K191332.

Who is the listed applicant for XACT Robotic System?

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

What is the FDA product code for XACT Robotic System?

The FDA product code for XACT Robotic System is JAK.

其他以 Xact Robotics, Ltd. 為申請人之記錄

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相關器械（代碼：JAK）

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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