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FDA 510(k), K183437, AirRay Subdural Cortical Electrodes
FDA 510(k), K183437, AirRay Subdural Cortical Electrodes
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510(K) Number: K183437
Device Name: AirRay Subdural Cortical Electrodes
Manufacturer: CorTec GmbH
Device Classification Name: electrode, cortical
Regulation Number: 882.1310
Classification Product Code: GYC
Date Received: 12/12/2018
Decision Date: 03/12/2019
Regulation Medical Specialty: Neurology
Device Name: AirRay Subdural Cortical Electrodes
Manufacturer: CorTec GmbH
Device Classification Name: electrode, cortical
Regulation Number: 882.1310
Classification Product Code: GYC
Date Received: 12/12/2018
Decision Date: 03/12/2019
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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