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FDA 510(k)

AirRay Subdural Cortical Electrodes

K-Number: K183437 · 2019-03-12

ApplicantCortec GmbH
Decision Date2019-03-12
Product CodeGYC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Cortec GmbH. The 510(k) number is K183437.

When was AirRay Subdural Cortical Electrodes approved by the FDA?

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

What company makes AirRay Subdural Cortical Electrodes?

AirRay Subdural Cortical Electrodes is manufactured by Cortec GmbH.

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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