FDA 510(k)

Hospira 扩展套件

K号: K151969 · 2016-01-19

决定日期2016-01-19

产品代码FPA

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

Hospira Extension Sets is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical, Inc.. It received FDA 510(k) clearance on 2016-01-19 under 510(k) number K151969. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Hospira Extension Sets?

Hospira Extension Sets is a medical device that received FDA 510(k) clearance on 2016-01-19. The listed applicant is Icu Medical, Inc.. The 510(k) number is K151969.

When did Hospira Extension Sets receive FDA 510(k) clearance?

Hospira Extension Sets received FDA 510(k) clearance on 2016-01-19, under 510(k) number K151969.

Who is the listed applicant for Hospira Extension Sets?

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

What is the FDA product code for Hospira Extension Sets?

The FDA product code for Hospira Extension Sets is FPA.

列明Icu 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。

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相关器械（代码：FPA）

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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