FDA 510(k)

1688 4K 摄像机控制单元，具有高级成像功能（1688010000）

K号: K230216 · 2023-02-23

决定日期2023-02-23

产品代码GCJ

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决定实质等同

器械摘要

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2023-02-23 under 510(k) number K230216. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)?

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) is a medical device that received FDA 510(k) clearance on 2023-02-23. The listed applicant is Stryker. The 510(k) number is K230216.

When did 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) receive FDA 510(k) clearance?

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) received FDA 510(k) clearance on 2023-02-23, under 510(k) number K230216.

Who is the listed applicant for 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)?

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

What is the FDA product code for 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)?

The FDA product code for 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) is GCJ.

列明Stryker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。

K2318541788 4K相机系统，具有高级成像模式；L12 LED光源与AIM K230416Triathlon®铰链膝关节系统；Triathlon®修订型植入物X3®K230754L12 LED 光源带AIM K2306051788 4K相机系统，具有高级成像模式 K2221301688 4K 摄像机系统，具有高级成像功能 K220731Insignia髋关节假体，Restoration模块115mm锥形远端假体

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相关器械（代码：GCJ）

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。

K262397CuratOR EX2742Eizo Corporation K260884UNIDRIVE选择系统Karl Storz SE & CO. KG K260972OEV-271MUH 液晶显示器；OEV-321MUH 液晶显示器；OEV-431MUH 液晶显示器Sony Corporation K261139VereSee（VER150、VER200、VER151、VER201、VER200C和VER-100-103）Freyja Healthcare, LLC K253541EZ-Close™（EZ Close 端口部位闭合装置，EZ Close MAX 端口部位闭合装置，EZ Close II 端口部位闭合装置）Medical Impact K261614LED液晶显示器（OEV-271H）Lg Electronics.Inc

官方来源

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