FDA 510(k)

SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles

K-번호: K160294 · 2016-10-21

결정일2016-10-21

제품 코드BSP

자문 위원회AN

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

PAJUNK GmbH Medizintechnologie를 신청인으로 등재한 기타 기록

K243690SonoMSK K243682SonoPlex STIM; SonoPlex II K250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture K243525SonoTAP and SonoTAP II K241953SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology K241954SonoBlock; SonoBlock II

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