FDA 510(k)

IRRAflow CNS System

N.º K: K171880 · 2018-07-13

Fecha de decisión2018-07-13

Código de productoJXG

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

IRRAflow CNS System is the device name listed in this FDA 510(k) record. The listed applicant is Irras, Inc.. It received FDA 510(k) clearance on 2018-07-13 under 510(k) number K171880. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the IRRAflow CNS System?

IRRAflow CNS System is a medical device that received FDA 510(k) clearance on 2018-07-13. The listed applicant is Irras, Inc.. The 510(k) number is K171880.

When did IRRAflow CNS System receive FDA 510(k) clearance?

IRRAflow CNS System received FDA 510(k) clearance on 2018-07-13, under 510(k) number K171880.

Who is the listed applicant for IRRAflow CNS System?

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

What is the FDA product code for IRRAflow CNS System?

The FDA product code for IRRAflow CNS System is JXG.

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Fuente oficial

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