FDA 510(k)

AirRay Subdural Cortical Electrodes

Número K: K183437 · 2019-03-12

Data da decisão2019-03-12

Código do produtoGYC

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

AirRay Subdural Cortical Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Cortec GmbH. It received FDA 510(k) clearance on 2019-03-12 under 510(k) number K183437. The device is classified under product code GYC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AirRay Subdural Cortical Electrodes?

AirRay Subdural Cortical Electrodes is a medical device that received FDA 510(k) clearance on 2019-03-12. The listed applicant is Cortec GmbH. The 510(k) number is K183437.

When did AirRay Subdural Cortical Electrodes receive FDA 510(k) clearance?

AirRay Subdural Cortical Electrodes received FDA 510(k) clearance on 2019-03-12, under 510(k) number K183437.

Who is the listed applicant for AirRay Subdural Cortical Electrodes?

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

What is the FDA product code for AirRay Subdural Cortical Electrodes?

The FDA product code for AirRay Subdural Cortical Electrodes is GYC.

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