Clearance Summary
CES ULTRA received FDA 510(k) clearance under submission number K062284, sponsored by Neuro-Fitness, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2007-04-05.
- Submission: K062284
- Applicant / Sponsor: Neuro-Fitness, LLC
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5800
- Decision date: 2007-04-05
Classification & Regulation
This clearance is catalogued under FDA product code QJQ and 21 CFR 882.5800, within the Neurology review panel as a Class II device.