FDA 510(k)

VitalFlow™ Console

Número K: K230364 · 2023-08-25

RequerenteMichigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)

Data da decisão2023-08-25

Código do produtoQNR

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

VitalFlow™ Console is the device name listed in this FDA 510(k) record. The listed applicant is Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.). It received FDA 510(k) clearance on 2023-08-25 under 510(k) number K230364. The device is classified under product code QNR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VitalFlow™ Console?

VitalFlow™ Console is a medical device that received FDA 510(k) clearance on 2023-08-25. The listed applicant is Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.). The 510(k) number is K230364.

When did VitalFlow™ Console receive FDA 510(k) clearance?

VitalFlow™ Console received FDA 510(k) clearance on 2023-08-25, under 510(k) number K230364.

Who is the listed applicant for VitalFlow™ Console?

The FDA 510(k) record lists Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VitalFlow™ Console?

The FDA product code for VitalFlow™ Console is QNR.

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Outros registros que listam Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) como candidato(a)

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Fonte oficial

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