Clearance Summary
BALL RECORDING ELECTRODE/STIMULATION PROBE received FDA 510(k) clearance under submission number K030517, sponsored by Viasys Healthcare, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2003-08-01.
- Submission: K030517
- Applicant / Sponsor: Viasys Healthcare, Inc.
- Clearance pathway: Abbreviated
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1340
- Decision date: 2003-08-01
Classification & Regulation
This clearance is catalogued under FDA product code GZK and 21 CFR 882.1340, within the Neurology review panel as a Class II device.