FDA 510(k)

TipVision視覺內視鏡系統（TipVision VideoScope 0°/30°；EleVision HD 2 開關控制單元（CCU））

K 號：K201617 · 2021-03-12

決定日期2021-03-12

產品代碼HET

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) is the device name listed in this FDA 510(k) record. The listed applicant is Schoelly Fiberoptic GmbH. It received FDA 510(k) clearance on 2021-03-12 under 510(k) number K201617. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))?

TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) is a medical device that received FDA 510(k) clearance on 2021-03-12. The listed applicant is Schoelly Fiberoptic GmbH. The 510(k) number is K201617.

When did TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) receive FDA 510(k) clearance?

TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) received FDA 510(k) clearance on 2021-03-12, under 510(k) number K201617.

Who is the listed applicant for TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))?

The FDA 510(k) record lists Schoelly Fiberoptic GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))?

The FDA product code for TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) is HET.

其他以 Schoelly Fiberoptic GmbH 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。

K233225SCHOELLY 氧飽和成像 (OSI) 相機系統（相機控制單元，相機頭將與光纖內視鏡相連接）K221591相機系統（相機控制單元、將與光纖內視鏡相連的相機頭），近紅外線光源 K201970Schoelly 腹腔鏡/宮腔鏡及附件 K151308Schoelly腎鏡組合，Schoelly超迷你腎鏡組合

相關器械（代碼：HET）

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。

K250939SIRIUS內視鏡系統（PR-SI-1230）Precision Robotics (Hong Kong) Limited K243821i-CutA.M.I. Agency For Medical Innovations GmbH K221642SIRIUS內視鏡系統Precision Robotics (Hong Kong) Limited K210116視頻內視鏡系統，3D視頻內視鏡系統Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.K201832Endoeye Flex 可變向視鏡與利康 LTF-S190-5Olympus Medical Systems Corp.K210104SurroundScope 系統270surgical , Ltd.

官方來源

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