FDA 510(k)

Sistema de Infusão Agilia SP, Bomba de Infusão Agilia SP MC WIFI, Agilia Link, Agilia Duo, Cabo USB Agilia

Número K: K210074 · 2022-03-01

Data da decisão2022-03-01

Código do produtoFRN

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable 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 K210074. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable?

Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable 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 K210074.

When did Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable receive FDA 510(k) clearance?

Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable received FDA 510(k) clearance on 2022-03-01, under 510(k) number K210074.

Who is the listed applicant for Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable?

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 Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable?

The FDA product code for Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable is FRN.

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

K251139KabiHelp® Uno; KabiHelp® Advance plus K212445freeflex+ Transfer Adapter K210075Vigilant Software Suite – Vigilant Master Med K210073Sistema de Infusão Agilia VP, Bomba de Infusão Agilia VP MC WIFI, Conjuntos de Administração de Linhas Volumat, Agilia Link, Agilia Duo K210089CATSmart, Automated Blood Processing Autotransfusion System K200530Sistema de Separador AMICUS

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