FDA 510(k)

SPROTTE NRFit, Quincke NRFit

K号: K160295 · 2016-10-27

决定日期2016-10-27

产品代码BSP

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决定实质等同

器械摘要

SPROTTE NRFit, Quincke NRFit is the device name listed in this FDA 510(k) record. The listed applicant is PAJUNK GmbH Medizintechnologie. It received FDA 510(k) clearance on 2016-10-27 under 510(k) number K160295. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SPROTTE NRFit, Quincke NRFit?

SPROTTE NRFit, Quincke NRFit is a medical device that received FDA 510(k) clearance on 2016-10-27. The listed applicant is PAJUNK GmbH Medizintechnologie. The 510(k) number is K160295.

When did SPROTTE NRFit, Quincke NRFit receive FDA 510(k) clearance?

SPROTTE NRFit, Quincke NRFit received FDA 510(k) clearance on 2016-10-27, under 510(k) number K160295.

Who is the listed applicant for SPROTTE NRFit, Quincke NRFit?

The FDA 510(k) record lists PAJUNK GmbH Medizintechnologie as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPROTTE NRFit, Quincke NRFit?

The FDA product code for SPROTTE NRFit, Quincke NRFit is BSP.

列明PAJUNK GmbH Medizintechnologie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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官方来源

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