FDA 510(k)

ActiveCare Home

Número K: K160431 · 2016-07-13

RequerenteMedical Compression Systems (Dbn) , Ltd.

Data da decisão2016-07-13

Código do produtoJOW

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

ActiveCare Home is the device name listed in this FDA 510(k) record. The listed applicant is Medical Compression Systems (Dbn) , Ltd.. It received FDA 510(k) clearance on 2016-07-13 under 510(k) number K160431. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ActiveCare Home?

ActiveCare Home is a medical device that received FDA 510(k) clearance on 2016-07-13. The listed applicant is Medical Compression Systems (Dbn) , Ltd.. The 510(k) number is K160431.

When did ActiveCare Home receive FDA 510(k) clearance?

ActiveCare Home received FDA 510(k) clearance on 2016-07-13, under 510(k) number K160431.

Who is the listed applicant for ActiveCare Home?

The FDA 510(k) record lists Medical Compression Systems (Dbn) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ActiveCare Home?

The FDA product code for ActiveCare Home is JOW.

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