FDA 510(k)

TipVision 视频内窥镜系统（TipVision 视频内窥镜 0°/30°；EleVision HD 2 摄像机控制单元（CCU））

K号: K201617 · 2021-03-12

决定日期2021-03-12

产品代码HET

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决定实质等同

器械摘要

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.

常见问题

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.

列明Schoelly Fiberoptic GmbH为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K233225SCHOELLY 氧饱和度成像 (OSI) 摄像机系统（摄像机控制单元，摄像机头需连接到光纤内窥镜）K221591摄像头系统（摄像头控制单元，摄像头头连接到光纤内窥镜），NIR FI 光源 K201970Schoelly膀胱镜/宫腔镜及其附件 K151308Schoelly肾镜套装，Schoelly超迷你肾镜套装

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。