Clearance Summary
LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812 received FDA 510(k) clearance under submission number K023472, sponsored by Class A Enterprises, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2003-03-18.
- Submission: K023472
- Applicant / Sponsor: Class A Enterprises, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1350
- Decision date: 2003-03-18
Classification & Regulation
This clearance is catalogued under FDA product code GXZ and 21 CFR 882.1350, within the Neurology review panel as a Class II device.