FDA 510(k)

Reprocesses Umbilical Cable

Número K: K221854 · 2022-08-06

Data da decisão2022-08-06

Código do produtoNLH

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Reprocesses Umbilical Cable is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health, LLC. It received FDA 510(k) clearance on 2022-08-06 under 510(k) number K221854. The device is classified under product code NLH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Reprocesses Umbilical Cable?

Reprocesses Umbilical Cable is a medical device that received FDA 510(k) clearance on 2022-08-06. The listed applicant is Innovative Health, LLC. The 510(k) number is K221854.

When did Reprocesses Umbilical Cable receive FDA 510(k) clearance?

Reprocesses Umbilical Cable received FDA 510(k) clearance on 2022-08-06, under 510(k) number K221854.

Who is the listed applicant for Reprocesses Umbilical Cable?

The FDA 510(k) record lists Innovative Health, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reprocesses Umbilical Cable?

The FDA product code for Reprocesses Umbilical Cable is NLH.

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Fonte oficial

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