FDA 510(k)

SURGIVISIO 裝置

K 號：K220946 · 2022-04-15

決定日期2022-04-15

產品代碼OWB

諮詢委員會RA

決定相當於

器材摘要

SURGIVISIO Device is the device name listed in this FDA 510(k) record. The listed applicant is Ecential Robotics. It received FDA 510(k) clearance on 2022-04-15 under 510(k) number K220946. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SURGIVISIO Device?

SURGIVISIO Device is a medical device that received FDA 510(k) clearance on 2022-04-15. The listed applicant is Ecential Robotics. The 510(k) number is K220946.

When did SURGIVISIO Device receive FDA 510(k) clearance?

SURGIVISIO Device received FDA 510(k) clearance on 2022-04-15, under 510(k) number K220946.

Who is the listed applicant for SURGIVISIO Device?

FDA 510(k) 記錄將 Ecential Robotics 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for SURGIVISIO Device?

The FDA product code for SURGIVISIO Device is OWB.

其他以 Ecential Robotics 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。

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相關器械（代碼：OWB）

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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