FDA 510(k)

Radiance Ultra 系列ZeroWire 内置

K号: K161228 · 2016-05-26

决定日期2016-05-26

产品代码GCJ

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决定实质等同

器械摘要

Radiance Ultra Series ZeroWire Embedded is the device name listed in this FDA 510(k) record. The listed applicant is Nds Surgical Imaging, LLC. It received FDA 510(k) clearance on 2016-05-26 under 510(k) number K161228. 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 Radiance Ultra Series ZeroWire Embedded?

Radiance Ultra Series ZeroWire Embedded is a medical device that received FDA 510(k) clearance on 2016-05-26. The listed applicant is Nds Surgical Imaging, LLC. The 510(k) number is K161228.

When did Radiance Ultra Series ZeroWire Embedded receive FDA 510(k) clearance?

Radiance Ultra Series ZeroWire Embedded received FDA 510(k) clearance on 2016-05-26, under 510(k) number K161228.

Who is the listed applicant for Radiance Ultra Series ZeroWire Embedded?

The FDA 510(k) record lists Nds Surgical Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Radiance Ultra Series ZeroWire Embedded?

The FDA product code for Radiance Ultra Series ZeroWire Embedded is GCJ.

列明Nds Surgical Imaging, LLC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。

K222890RADIANCE ULTRA 32 4K ZEROWIRE DUO K170598ZeroWire 移动设备

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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