FDA 510(k)

PK AIM

K号: K161825 · 2016-09-26

决定日期2016-09-26

产品代码GEI

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决定实质等同

器械摘要

PK AIM is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2016-09-26 under 510(k) number K161825. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PK AIM?

PK AIM is a medical device that received FDA 510(k) clearance on 2016-09-26. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K161825.

When did PK AIM receive FDA 510(k) clearance?

PK AIM received FDA 510(k) clearance on 2016-09-26, under 510(k) number K161825.

Who is the listed applicant for PK AIM?

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

What is the FDA product code for PK AIM?

The FDA product code for PK AIM is GEI.

列明Gyrus Acmi, 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。

K252487POWERSEAL 开放扩展嘴封口器和分隔器，双动作（PS-0021EJDA）K233275RenaFlex 单次使用柔性输尿管镜（SUURF-V 标准型）；RenaFlex 单次使用柔性输尿管镜（SUURF-VR 反向型）；单次使用内窥镜视频系统中心（CV-S1）K231327POWERSEAL 封口器和分隔器 K221306SOLTIVE Pro超脉冲激光，SOLTIVE Premium超脉冲激光，SOLTIVE超脉冲激光光纤和附件 K212650Celeris, 一次性窦道清创器 K213831Olympus PK 电外科器械，PK J钩，PK 刮刀，PK 针

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相关器械（代码：GEI）

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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