FDA 510(k)

医疗视频内窥镜系统

K号: K171076 · 2017-05-05

申请人Zhuhai Pusen Medical Technology Co., Ltd.

决定日期2017-05-05

产品代码FGB

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决定实质等同

器械摘要

Medical Video Endoscope System is the device name listed in this FDA 510(k) record. The listed applicant is Zhuhai Pusen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-05-05 under 510(k) number K171076. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Medical Video Endoscope System?

Medical Video Endoscope System is a medical device that received FDA 510(k) clearance on 2017-05-05. The listed applicant is Zhuhai Pusen Medical Technology Co., Ltd.. The 510(k) number is K171076.

When did Medical Video Endoscope System receive FDA 510(k) clearance?

Medical Video Endoscope System received FDA 510(k) clearance on 2017-05-05, under 510(k) number K171076.

Who is the listed applicant for Medical Video Endoscope System?

The FDA 510(k) record lists Zhuhai Pusen Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Video Endoscope System?

The FDA product code for Medical Video Endoscope System is FGB.

列明Zhuhai Pusen Medical Technology Co., Ltd.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。

K260521ClearEVAC输尿管吸引接入鞘（PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250）K233778单次使用吸引式输尿管镜（PU400A，PU411A），单次使用柔性视频输尿管镜（PU3033H，PU3033AH）K223741Pusen 单次使用柔性视频膀胱镜/胆道镜系统（单次使用柔性视频膀胱镜/胆道镜：PC200-AS，PC200-AR，PC200-S和PC200-R；高清医用视频内镜图像处理器：PV300）K222602Pusen 单次使用柔性视频膀胱镜系统（单次使用柔性视频膀胱镜：PC200-AS，PC200-AR，PC200-S和PC200-R；高清医用视频内镜图像处理器：PV300）K190648Pusen Eview Medical Video Endoscope Image Processor K172098医疗视频内窥镜系统

查看所有 7 个设备 →

相关器械（代码：FGB）

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。

K261447CVAC® 吸引系统Calyxo, Inc.K262488一次性使用视频软性输尿管肾镜（RP-U-C06R9，RP-U-C06R3，RP-U-C06S9，RP-U-C06S3）Guangzhou Red Pine Medical Instrument Co., Ltd.K261153LithoVue Elite 数字柔性输尿管镜系统Boston Scientific Corporation K262552一次性使用柔性输尿管镜（一次性使用柔性输尿管镜：SUV-5C-B）Scivita Medical Technology Co., Ltd.K253505Zamenix™ PRoen Surgical, Inc.K260516BubbleView 单次使用数字柔性膀胱镜（C38-CS，C38-CRS，C50-C，C50-CR，C50-CB，C50-CBR）MacroLux Medical Technology Co., Ltd.

官方来源

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