Clearance Summary
NICOLETONE SYSTEM V32 AMPLIFIER received FDA 510(k) clearance under submission number K061908, sponsored by Viasys Neuro Care. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2006-11-06.
- Submission: K061908
- Applicant / Sponsor: Viasys Neuro Care
- Clearance pathway: Abbreviated
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2006-11-06
Classification & Regulation
This clearance is catalogued under FDA product code GWQ and 21 CFR 882.1400, within the Neurology review panel as a Class II device.