FDA 510(k)

DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables

Número K: K152670 · 2016-01-22

Data da decisão2016-01-22

Código do produtoGWM

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2016-01-22 under 510(k) number K152670. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables?

DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables is a medical device that received FDA 510(k) clearance on 2016-01-22. The listed applicant is Medos International SARL. The 510(k) number is K152670.

When did DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables receive FDA 510(k) clearance?

DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables received FDA 510(k) clearance on 2016-01-22, under 510(k) number K152670.

Who is the listed applicant for DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables?

The FDA 510(k) record lists Medos International SARL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables?

The FDA product code for DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables is GWM.

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