FDA 510(k)

InPen

K号: K160629 · 2016-07-26

决定日期2016-07-26

产品代码FMF

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

InPen is the device name listed in this FDA 510(k) record. The listed applicant is Companion Medical, Inc.. It received FDA 510(k) clearance on 2016-07-26 under 510(k) number K160629. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the InPen?

InPen is a medical device that received FDA 510(k) clearance on 2016-07-26. The listed applicant is Companion Medical, Inc.. The 510(k) number is K160629.

When did InPen receive FDA 510(k) clearance?

InPen received FDA 510(k) clearance on 2016-07-26, under 510(k) number K160629.

Who is the listed applicant for InPen?

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

What is the FDA product code for InPen?

The FDA product code for InPen is FMF.

列明Companion Medical, 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。

K201337InPen系统 K190487InPen剂量计算器 K192841InPen系统 K181327InPen剂量计算器

相关器械（代码：FMF）

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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官方来源

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