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FDA 510(k)

Hypocore

N.º K: K153162 · 2016-05-24

SolicitanteNovocor Medical Systems, Inc.
Fecha de decisión2016-05-24
Código de productoNCX
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

Hypocore is the device name listed in this FDA 510(k) record. The listed applicant is Novocor Medical Systems, Inc.. It received FDA 510(k) clearance on 2016-05-24 under 510(k) number K153162. The device is classified under product code NCX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Hypocore?

Hypocore is a medical device that received FDA 510(k) clearance on 2016-05-24. The listed applicant is Novocor Medical Systems, Inc.. The 510(k) number is K153162.

When did Hypocore receive FDA 510(k) clearance?

Hypocore received FDA 510(k) clearance on 2016-05-24, under 510(k) number K153162.

Who is the listed applicant for Hypocore?

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

What is the FDA product code for Hypocore?

The FDA product code for Hypocore is NCX.

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Fuente oficial

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