Clearance Summary
NEURODRIVE SYSTEM received FDA 510(k) clearance under submission number K051830, sponsored by Alpha Omega , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2005-09-16.
- Submission: K051830
- Applicant / Sponsor: Alpha Omega , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1330
- Decision date: 2005-09-16
Classification & Regulation
This clearance is catalogued under FDA product code GZL and 21 CFR 882.1330, within the Neurology review panel as a Class II device.