FDA 510(k)

Stryker SDC3 HD信息管理系统，具有无线设备控制功能

K号: K160332 · 2016-05-18

决定日期2016-05-18

产品代码GCJ

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

Stryker SDC3 HD Information Management System with Wireless Device Control Capability is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 2016-05-18 under 510(k) number K160332. 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 Stryker SDC3 HD Information Management System with Wireless Device Control Capability?

Stryker SDC3 HD Information Management System with Wireless Device Control Capability is a medical device that received FDA 510(k) clearance on 2016-05-18. The listed applicant is Stryker Endoscopy. The 510(k) number is K160332.

When did Stryker SDC3 HD Information Management System with Wireless Device Control Capability receive FDA 510(k) clearance?

Stryker SDC3 HD Information Management System with Wireless Device Control Capability received FDA 510(k) clearance on 2016-05-18, under 510(k) number K160332.

Who is the listed applicant for Stryker SDC3 HD Information Management System with Wireless Device Control Capability?

FDA 510(k)记录显示Stryker Endoscopy为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Stryker SDC3 HD Information Management System with Wireless Device Control Capability?

The FDA product code for Stryker SDC3 HD Information Management System with Wireless Device Control Capability is GCJ.

列明Stryker Endoscopy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。

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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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