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FDA 510(k)

UA-Cellular 完整版

K号: K170091 · 2017-02-09

申请人Streck
决定日期2017-02-09
产品代码JJW
咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同

器械摘要

UA-Cellular Complete is the device name listed in this FDA 510(k) record. The listed applicant is Streck. It received FDA 510(k) clearance on 2017-02-09 under 510(k) number K170091. The device is classified under product code JJW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the UA-Cellular Complete?

UA-Cellular Complete is a medical device that received FDA 510(k) clearance on 2017-02-09. The listed applicant is Streck. The 510(k) number is K170091.

When did UA-Cellular Complete receive FDA 510(k) clearance?

UA-Cellular Complete received FDA 510(k) clearance on 2017-02-09, under 510(k) number K170091.

Who is the listed applicant for UA-Cellular Complete?

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

What is the FDA product code for UA-Cellular Complete?

The FDA product code for UA-Cellular Complete is JJW.

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Streck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。

K254166MDx-Chex 用于 BCNK231223MDx-Chex 用于 BC-GNK231221MDx-Chex 用于 BC-GPK160585XN 医疗设备K160590XN CHECKK160588XN CHECK BF

查看所有 8 个设备 →

官方来源

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