Search Results
Found 1 results
510(k) Data Aggregation
K Number
K183437Device Name
AirRay Subdural Cortical Electrodes
Manufacturer
CorTec GmbH
Date Cleared
2019-03-12
(90 days)
Product Code
GYC
Regulation Number
882.1310Why did this record match?
Applicant Name (Manufacturer) :
CorTec GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The °AirRay® Subdural Cortical Electrodes (Strips and Grids) are intended for temporary (<30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface level of the brain. The recording of electrical activity supports definition of epileptogenic foci and brain mapping.
Device Description
The ° AirRay® Subdural Cortical Electrodes Subdural electrodes are single patient use, disposable, sterile devices. The electrodes are invasive as they are placed in contact with the brain. The electrodes provide the patient contact device. The electrodes connect to the user's recording, monitoring and stimulation/response equipment. The electrodes are used under the supervision of a physicians in the areas of biopotential recording, monitoring and stimulation/response studies understand the use of subdural electrodes.
Ask a Question
Page 1 of 1