FDA 510(k)

SIMPLYSTRONG, SIMPLYEZEE

K号: K181791 · 2018-08-21

决定日期2018-08-21

产品代码GCJ

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决定实质等同

器械摘要

SIMPLYSTRONG, SIMPLYEZEE is the device name listed in this FDA 510(k) record. The listed applicant is Genicon, Inc.. It received FDA 510(k) clearance on 2018-08-21 under 510(k) number K181791. 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 SIMPLYSTRONG, SIMPLYEZEE?

SIMPLYSTRONG, SIMPLYEZEE is a medical device that received FDA 510(k) clearance on 2018-08-21. The listed applicant is Genicon, Inc.. The 510(k) number is K181791.

When did SIMPLYSTRONG, SIMPLYEZEE receive FDA 510(k) clearance?

SIMPLYSTRONG, SIMPLYEZEE received FDA 510(k) clearance on 2018-08-21, under 510(k) number K181791.

Who is the listed applicant for SIMPLYSTRONG, SIMPLYEZEE?

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

What is the FDA product code for SIMPLYSTRONG, SIMPLYEZEE?

The FDA product code for SIMPLYSTRONG, SIMPLYEZEE is GCJ.

列明Genicon, Inc.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。

K190168Aquas 探针 K180836Genistrong K180579Ezee Retrieval K171752X-手术 K162059EZEE 检索

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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