FDA 510(k)

PENTAX 医疗 VIVIDEO 耳鼻喉视频内镜解决方案

K号: K171011 · 2018-07-18

决定日期2018-07-18

产品代码EOB

咨询委员会医疗设备监管文本描述翻译如下：关于[公司/产品名称]的监管信息： - 美国食品药品监督管理局（FDA）批准号：[510(k)编号] - 预市场批准（PMA）申请号：[PMA编号] - 临床试验注册号（NCT）：[NCT编号] - 医学文献标识符（PMID）：[PMID编号] - 产品标识符：[标识符] - 相关政策：医疗监管政策v1 - 更多信息请访问：[URL] 请注意，以上翻译保留了公司/产品名称、FDA、510(k)、PMA、NCT、PMID、标识符和URL。

决定实质等同

器械摘要

PENTAX Medical VIVIDEO ENT Videoscope Solution is the device name listed in this FDA 510(k) record. The listed applicant is Pentax Medical. It received FDA 510(k) clearance on 2018-07-18 under 510(k) number K171011. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PENTAX Medical VIVIDEO ENT Videoscope Solution?

PENTAX Medical VIVIDEO ENT Videoscope Solution is a medical device that received FDA 510(k) clearance on 2018-07-18. The listed applicant is Pentax Medical. The 510(k) number is K171011.

When did PENTAX Medical VIVIDEO ENT Videoscope Solution receive FDA 510(k) clearance?

PENTAX Medical VIVIDEO ENT Videoscope Solution received FDA 510(k) clearance on 2018-07-18, under 510(k) number K171011.

Who is the listed applicant for PENTAX Medical VIVIDEO ENT Videoscope Solution?

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

What is the FDA product code for PENTAX Medical VIVIDEO ENT Videoscope Solution?

The FDA product code for PENTAX Medical VIVIDEO ENT Videoscope Solution is EOB.

列明Pentax Medical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。

K192280PENTAX 医疗 ED-3490TK 视频十二指肠镜 K172156PENTAX 医疗 EPK-3000 视频成像系统 K161222PENTAX MEDICAL ED-3490TK，视频十二指肠镜 K163614PENTAX 医疗 ED34-i10T, 视频十二指肠镜

相关器械（代码：EOB）

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。

K254299清晰视野冲洗套管 0°（7241AS）；清晰视野冲洗套管 30°（7241BS）；清晰视野冲洗套管 45°（7241FS）Karl Storz SE & CO. KG K261544Hydro 灌洗系统Stryker Instruments K254133ENTity USB 视频内窥镜系统Optim, LLC K253184视频鼻咽喉镜系统（一次性视频鼻咽喉镜SP11A 内窥镜视频处理器M110B）Zhuhai Wesee Meditech Co., Ltd.K252050一次性活检镊 FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems Corporation K241731Outlook外科Versa One系统（8900139）Resnent, LLC

官方来源

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