510(k) K183437
K183437 is an FDA 510(k) premarket notification submitted by Cortec GmbH for the device "AirRay Subdural Cortical Electrodes". The FDA issued a decision of Substantially Equivalent on March 12, 2019. The device falls under product code GYC (Electrode, Cortical), a Class II device regulated under 21 CFR 882.1310.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 2019
- Date Received
- December 12, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Cortical
- Device Class
- Class II
- Regulation Number
- 882.1310
- Review Panel
- NE
- Submission Type