Clearance Summary
ALPHA DRIVE SYSTEM received FDA 510(k) clearance under submission number K013396, sponsored by Alpha Omega , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2002-08-07.
- Submission: K013396
- Applicant / Sponsor: Alpha Omega , Ltd.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2002-08-07
Classification & Regulation
This clearance is catalogued under FDA product code HAW and 21 CFR 882.4560, within the Neurology review panel as a Class II device.