FDA 510(k)

CereLink ICP Monitor

N.º K: K210993 · 2021-04-30

SolicitanteIntegra Lifesciences Production Corporation

Fecha de decisión2021-04-30

Código de productoGWM

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

CereLink ICP Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Production Corporation. It received FDA 510(k) clearance on 2021-04-30 under 510(k) number K210993. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CereLink ICP Monitor?

CereLink ICP Monitor is a medical device that received FDA 510(k) clearance on 2021-04-30. The listed applicant is Integra Lifesciences Production Corporation. The 510(k) number is K210993.

When did CereLink ICP Monitor receive FDA 510(k) clearance?

CereLink ICP Monitor received FDA 510(k) clearance on 2021-04-30, under 510(k) number K210993.

Who is the listed applicant for CereLink ICP Monitor?

The FDA 510(k) record lists Integra Lifesciences Production Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CereLink ICP Monitor?

The FDA product code for CereLink ICP Monitor is GWM.

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Dispositivos relacionados (Código: GWM)

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Fuente oficial

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