SPROTTE NRFit, Quincke NRFit
K-Number: K160295 · 2016-10-27
ApplicantPAJUNK GmbH Medizintechnologie
Decision Date2016-10-27
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
SPROTTE NRFit, Quincke NRFit is a medical device manufactured by PAJUNK GmbH Medizintechnologie. It received FDA 510(k) clearance on 2016-10-27 under approval number K160295. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
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. It is manufactured by PAJUNK GmbH Medizintechnologie. The 510(k) number is K160295.
When was SPROTTE NRFit, Quincke NRFit approved by the FDA?
SPROTTE NRFit, Quincke NRFit received FDA 510(k) clearance on 2016-10-27, under approval number K160295.
What company makes SPROTTE NRFit, Quincke NRFit?
SPROTTE NRFit, Quincke NRFit is manufactured by PAJUNK GmbH Medizintechnologie.
What is the FDA product code for SPROTTE NRFit, Quincke NRFit?
The FDA product code for SPROTTE NRFit, Quincke NRFit is BSP.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.