FDA-Approved EEG Headset
FDA Approved EEG Headset by CGX
FDA 510(k) Ready to market Notification Summary
Device Information
- Device Name: Quick-20m
- Classification Name: Amplifier, Physiological Signal
- 510(k) Number: K203331
- Product Code: GWL
- Subsequent Product Code: GXY
- Regulation Number: 882.1835
- Medical Specialty: Neurology
- Review Panel: Neurology
Submission & Decision
- Date Received: November 12, 2020
- Decision Date: May 20, 2021
- Decision: Substantially Equivalent (SE/SE)
- Review Type: Traditional
- Reviewed by Third Party: Yes
