FDA 510(k)

WAVE Clinical Platform

N.º K: K171056 · 2018-01-04

SolicitanteExcel Medical Electronics, LLC

Fecha de decisión2018-01-04

Código de productoMWI

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

WAVE Clinical Platform is the device name listed in this FDA 510(k) record. The listed applicant is Excel Medical Electronics, LLC. It received FDA 510(k) clearance on 2018-01-04 under 510(k) number K171056. 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 WAVE Clinical Platform?

WAVE Clinical Platform is a medical device that received FDA 510(k) clearance on 2018-01-04. The listed applicant is Excel Medical Electronics, LLC. The 510(k) number is K171056.

When did WAVE Clinical Platform receive FDA 510(k) clearance?

WAVE Clinical Platform received FDA 510(k) clearance on 2018-01-04, under 510(k) number K171056.

Who is the listed applicant for WAVE Clinical Platform?

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

What is the FDA product code for WAVE Clinical Platform?

The FDA product code for WAVE Clinical Platform is MWI.

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Fuente oficial

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