FDA 510(k)

Axeo 3 Patient Monitor

N.º K: K153079 · 2016-03-17

SolicitanteAxeo Medical Technologies, LLC

Fecha de decisión2016-03-17

Código de productoMWI

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Axeo 3 Patient Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Axeo Medical Technologies, LLC. It received FDA 510(k) clearance on 2016-03-17 under 510(k) number K153079. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Axeo 3 Patient Monitor?

Axeo 3 Patient Monitor is a medical device that received FDA 510(k) clearance on 2016-03-17. The listed applicant is Axeo Medical Technologies, LLC. The 510(k) number is K153079.

When did Axeo 3 Patient Monitor receive FDA 510(k) clearance?

Axeo 3 Patient Monitor received FDA 510(k) clearance on 2016-03-17, under 510(k) number K153079.

Who is the listed applicant for Axeo 3 Patient Monitor?

The FDA 510(k) record lists Axeo Medical Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Axeo 3 Patient Monitor?

The FDA product code for Axeo 3 Patient Monitor is MWI.

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Fuente oficial

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