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FDA 510(k)

PENTAX 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-i10cL

K号: K190805 · 2019-12-20

申请人Pentax of America, Inc.
决定日期2019-12-20
产品代码PEA
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL is the device name listed in this FDA 510(k) record. The listed applicant is Pentax of America, Inc.. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K190805. 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 PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL?

PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Pentax of America, Inc.. The 510(k) number is K190805.

When did PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL receive FDA 510(k) clearance?

PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL received FDA 510(k) clearance on 2019-12-20, under 510(k) number K190805.

Who is the listed applicant for PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL?

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

What is the FDA product code for PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL?

The FDA product code for PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL is PEA.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Pentax of America, 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。

K251256PENTAX 医疗视频上消化道镜 (EG 系列) (EG 系列)；PENTAX 医疗视频结肠镜 (EC 系列) (EC 系列)K251127PENTAX 医疗视频处理器 (EPK-i8020c)K242110PENTAX 医疗视频结肠镜 (EC38-i20cWL)K241213PENTAX 医疗视频上消化道镜 (EG27-i20c)；PENTAX 医疗视频结肠镜 (EC34-i20cL)K233942PENTAX 医疗视频十二指肠镜 (ED34-i10T2s)；PENTAX 医疗视频处理器 (EPK-i8020c)；PENTAX 医疗一次性，无菌远端帽带提升器 (OE-A63)；气/水供应阀门 (OF-B194 )K240457C2 冷冻球囊消融系统（C2 冷冻球囊消融系统）

查看所有 39 个设备 →

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.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.K160275带有FuseBox处理器的Fuse内窥镜系统Endochoice, Inc.

官方来源

在 FDA 数据库中查看 →

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。

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