FDA 510(k)

靈敏感應器-輸尿管鏡 BOA Vision EF，靈敏感應器-輸尿管鏡 COBRA Vision EF

K 號：K183188 · 2019-05-03

申請人Richard Wolf Medical Instruments Corporation

決定日期2019-05-03

產品代碼FGB

諮詢委員會GU

決定相當於

器材摘要

Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corporation. It received FDA 510(k) clearance on 2019-05-03 under 510(k) number K183188. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF?

Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF is a medical device that received FDA 510(k) clearance on 2019-05-03. The listed applicant is Richard Wolf Medical Instruments Corporation. The 510(k) number is K183188.

When did Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF receive FDA 510(k) clearance?

Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF received FDA 510(k) clearance on 2019-05-03, under 510(k) number K183188.

Who is the listed applicant for Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF?

The FDA 510(k) record lists Richard Wolf Medical Instruments Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF?

The FDA product code for Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF is FGB.

其他以 Richard Wolf Medical Instruments Corporation 為申請人之記錄

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相關器械（代碼：FGB）

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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