FDA 510(k)

Sistema de Informação de Cuidados Intensivos ARC (Sistema ARC)

Número K: K220117 · 2023-06-06

Data da decisão2023-06-06

Código do produtoMWI

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

ARC Intensive Care Information System (ARC System) is the device name listed in this FDA 510(k) record. The listed applicant is Ordinatrum Solutions. It received FDA 510(k) clearance on 2023-06-06 under 510(k) number K220117. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ARC Intensive Care Information System (ARC System)?

ARC Intensive Care Information System (ARC System) is a medical device that received FDA 510(k) clearance on 2023-06-06. The listed applicant is Ordinatrum Solutions. The 510(k) number is K220117.

When did ARC Intensive Care Information System (ARC System) receive FDA 510(k) clearance?

ARC Intensive Care Information System (ARC System) received FDA 510(k) clearance on 2023-06-06, under 510(k) number K220117.

Who is the listed applicant for ARC Intensive Care Information System (ARC System)?

The FDA 510(k) record lists Ordinatrum Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARC Intensive Care Information System (ARC System)?

The FDA product code for ARC Intensive Care Information System (ARC System) is MWI.

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