FDA 510(k)

Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6

Número K: K190663 · 2019-06-17

RequerentePAJUNK GmbH Medizintechnologie

Data da decisão2019-06-17

Código do produtoBSN

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 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 2019-06-17 under 510(k) number K190663. The device is classified under product code BSN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6?

Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 is a medical device that received FDA 510(k) clearance on 2019-06-17. The listed applicant is PAJUNK GmbH Medizintechnologie. The 510(k) number is K190663.

When did Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 receive FDA 510(k) clearance?

Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 received FDA 510(k) clearance on 2019-06-17, under 510(k) number K190663.

Who is the listed applicant for Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6?

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 Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6?

The FDA product code for Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 is BSN.

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Outros registros que listam PAJUNK GmbH Medizintechnologie como candidato(a)

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