FDA 510(k)

带有FuseBox处理器的Fuse内窥镜系统

K号: K160275 · 2016-08-01

决定日期2016-08-01

产品代码PEA

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决定实质等同

器械摘要

Fuse Endoscopic System with FuseBox Processor is the device name listed in this FDA 510(k) record. The listed applicant is Endochoice, Inc.. It received FDA 510(k) clearance on 2016-08-01 under 510(k) number K160275. The device is classified under product code PEA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Fuse Endoscopic System with FuseBox Processor?

Fuse Endoscopic System with FuseBox Processor is a medical device that received FDA 510(k) clearance on 2016-08-01. The listed applicant is Endochoice, Inc.. The 510(k) number is K160275.

When did Fuse Endoscopic System with FuseBox Processor receive FDA 510(k) clearance?

Fuse Endoscopic System with FuseBox Processor received FDA 510(k) clearance on 2016-08-01, under 510(k) number K160275.

Who is the listed applicant for Fuse Endoscopic System with FuseBox Processor?

The FDA 510(k) record lists Endochoice, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fuse Endoscopic System with FuseBox Processor?

The FDA product code for Fuse Endoscopic System with FuseBox Processor is PEA.

列明Endochoice, Inc.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。

K161482EndoChoice 水瓶盖冲洗系统 K161167Seal 单次使用活检阀 K160403SmartStart 空气/水及吸引阀 K153588EndoChoice 水瓶盖系统 K151475EndoChoice Select 注射针

相关器械（代码：PEA）

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。

K251127PENTAX 医疗视频处理器 (EPK-i8020c)Pentax of America, Inc.K231249PENTAX 医疗视频处理器 EPK-i8020c，PENTAX 医疗视频上消化道镜 EG29-i20c，PENTAX 医疗视频结肠镜 EC38-i20cLPentax of America, Inc.K190805PENTAX 医疗视频处理器 EPK-i5500c，PENTAX 医疗视频上消化道镜 EG29-i10c，PENTAX 医疗视频结肠镜 EC34-i10cL，PENTAX 医疗视频结肠镜 EC38-i10cLPentax of America, Inc.K191282PENTAX 医疗 EPK-i7010 和 PENTAX EPK-i5010 视频处理器带 GI 系列内镜Pentax of America, Inc.K173679PENTAX 医疗 EPK-i7010 视频处理器带 EB 系列内镜Pentax of America, Inc.

官方来源

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