FDA 510(k)

真高清3MOS摄像头系统

K号: K161017 · 2016-05-09

决定日期2016-05-09

产品代码GCJ

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决定实质等同

器械摘要

True HD 3MOS Camera System is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2016-05-09 under 510(k) number K161017. 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 True HD 3MOS Camera System?

True HD 3MOS Camera System is a medical device that received FDA 510(k) clearance on 2016-05-09. The listed applicant is Conmed Corporation. The 510(k) number is K161017.

When did True HD 3MOS Camera System receive FDA 510(k) clearance?

True HD 3MOS Camera System received FDA 510(k) clearance on 2016-05-09, under 510(k) number K161017.

Who is the listed applicant for True HD 3MOS Camera System?

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

What is the FDA product code for True HD 3MOS Camera System?

The FDA product code for True HD 3MOS Camera System is GCJ.

列明Conmed Corporation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。

K261363Y-Knotless™ 无结锚 K253763Y-Knotless™ 无结锚 K252946BioBrace® 髋关节外韧带增强套件 K251530CONMED Argo Knotless® Anchor K250395BioBrace® RC 递送系统 K244025Argo 无结 GENESYS 锚

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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

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