FDA 510(k)

Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module

Número K: K161469 · 2017-03-28

Data da decisão2017-03-28

Código do produtoFRN

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module is the device name listed in this FDA 510(k) record. The listed applicant is Hospira, Inc.. It received FDA 510(k) clearance on 2017-03-28 under 510(k) number K161469. 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 Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module?

Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module is a medical device that received FDA 510(k) clearance on 2017-03-28. The listed applicant is Hospira, Inc.. The 510(k) number is K161469.

When did Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module receive FDA 510(k) clearance?

Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module received FDA 510(k) clearance on 2017-03-28, under 510(k) number K161469.

Who is the listed applicant for Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module?

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

What is the FDA product code for Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module?

The FDA product code for Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module is FRN.

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Fonte oficial

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