Clearance Summary
MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 received FDA 510(k) clearance under submission number K163547, sponsored by Neurovirtual USA, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2017-04-11.
- Submission: K163547
- Applicant / Sponsor: Neurovirtual USA, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 2017-04-11
Classification & Regulation
This clearance is catalogued under FDA product code GXY and 21 CFR 882.1320, within the Neurology review panel as a Class II device.