FDA 510(k)

SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology

Número K: K241953 · 2024-11-22

RequerentePAJUNK GmbH Medizintechnologie

Data da decisão2024-11-22

Código do produtoBSP

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology 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 2024-11-22 under 510(k) number K241953. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology?

SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology is a medical device that received FDA 510(k) clearance on 2024-11-22. The listed applicant is PAJUNK GmbH Medizintechnologie. The 510(k) number is K241953.

When did SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology receive FDA 510(k) clearance?

SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology received FDA 510(k) clearance on 2024-11-22, under 510(k) number K241953.

Who is the listed applicant for SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology?

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® STANDARD (LUER/ NRFit®) Anesthesiology?

The FDA product code for SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology is BSP.

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

K243690SonoMSK K243682SonoPlex STIM; SonoPlex II K250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture K243525SonoTAP and SonoTAP II K241954SonoBlock; SonoBlock II K230701Stim2Go

Ver todos os 21 dispositivos →

Dispositivos Relacionados (Código: BSP)

K243690SonoMSKPAJUNK GmbH Medizintechnologie K243682SonoPlex STIM; SonoPlex IIPAJUNK GmbH Medizintechnologie K250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PuncturePAJUNK GmbH Medizintechnologie K243525SonoTAP and SonoTAP IIPAJUNK GmbH Medizintechnologie K241954SonoBlock; SonoBlock IIPAJUNK GmbH Medizintechnologie K240253Reach NeedleAerin Medical, Inc.

Fonte oficial

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