FDA 510(k)

Vigilant Software Suite – Vigilant Master Med

N.º K: K210075 · 2022-03-01

Fecha de decisión2022-03-01

Código de productoPHC

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Fresenius Kabi AG como solicitante

K251139KabiHelp® Uno; KabiHelp® Advance plus K212445freeflex+ Transfer Adapter K210074Sistema de Infusión Agilia SP, Bomba de Infusión Agilia SP MC WIFI, Agilia Link, Agilia Duo, Cable USB Agilia K210073Sistema de Infusión Agilia VP, Bomba de Infusión Agilia VP MC WIFI, Jeringas de Administración Volumat Lines, Agilia Link, Agilia Duo K210089CATSmart, Automated Blood Processing Autotransfusion System K200530Sistema de Separador AMICUS

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Dispositivos relacionados (Código: PHC)

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Fuente oficial

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