FDA 510(k)

SPROTTE NRFit, Quincke NRFit 腰椎穿刺针

K号: K160294 · 2016-10-21

决定日期2016-10-21

产品代码BSP

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决定实质等同

器械摘要

SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles 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 2016-10-21 under 510(k) number K160294. 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 Lumbar Puncture needles?

SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles is a medical device that received FDA 510(k) clearance on 2016-10-21. The listed applicant is PAJUNK GmbH Medizintechnologie. The 510(k) number is K160294.

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

SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles received FDA 510(k) clearance on 2016-10-21, under 510(k) number K160294.

Who is the listed applicant for SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles?

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 Lumbar Puncture needles?

The FDA product code for SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles 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。

K243690SonoMSK K243682SonoPlex STIM；SonoPlex II K250774SPROTTE® 标准型 (LUER/ NRFit®) 腰椎穿刺 K243525SonoTAP和SonoTAP II K241953SPROTTE® 标准型 (LUER/ NRFit®) 麻醉学 K241954SonoBlock; SonoBlock II

查看所有 21 个设备 →

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。