FDA 510(k)

Pusen Eview Medical Video Endoscope Image Processor

K号: K190648 · 2019-03-29

申请人Zhuhai Pusen Medical Technology Co., Ltd.

决定日期2019-03-29

产品代码FET

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决定实质等同

器械摘要

Pusen Eview Medical Video Endoscope Image Processor 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 2019-03-29 under 510(k) number K190648. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Pusen Eview Medical Video Endoscope Image Processor?

Pusen Eview Medical Video Endoscope Image Processor is a medical device that received FDA 510(k) clearance on 2019-03-29. The listed applicant is Zhuhai Pusen Medical Technology Co., Ltd.. The 510(k) number is K190648.

When did Pusen Eview Medical Video Endoscope Image Processor receive FDA 510(k) clearance?

Pusen Eview Medical Video Endoscope Image Processor received FDA 510(k) clearance on 2019-03-29, under 510(k) number K190648.

Who is the listed applicant for Pusen Eview Medical Video Endoscope Image Processor?

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 Pusen Eview Medical Video Endoscope Image Processor?

The FDA product code for Pusen Eview Medical Video Endoscope Image Processor is FET.

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）K172098医疗视频内窥镜系统 K171076医疗视频内窥镜系统

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