FDA 510(k)

Vigilant Software Suite – Vigilant Master Med

Número K: K210075 · 2022-03-01

Data da decisão2022-03-01

Código do produtoPHC

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vigilant Software Suite – Vigilant Master Med is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Kabi AG. It received FDA 510(k) clearance on 2022-03-01 under 510(k) number K210075. The device is classified under product code PHC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Vigilant Software Suite – Vigilant Master Med?

Vigilant Software Suite – Vigilant Master Med is a medical device that received FDA 510(k) clearance on 2022-03-01. The listed applicant is Fresenius Kabi AG. The 510(k) number is K210075.

When did Vigilant Software Suite – Vigilant Master Med receive FDA 510(k) clearance?

Vigilant Software Suite – Vigilant Master Med received FDA 510(k) clearance on 2022-03-01, under 510(k) number K210075.

Who is the listed applicant for Vigilant Software Suite – Vigilant Master Med?

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

What is the FDA product code for Vigilant Software Suite – Vigilant Master Med?

The FDA product code for Vigilant Software Suite – Vigilant Master Med is PHC.

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Outros registros que listam Fresenius Kabi AG como candidato(a)

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Fonte oficial

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