Clearance Summary
EPI-SCAN, MODEL P 100 received FDA 510(k) clearance under submission number K032935, sponsored by Edx Epi-Scan, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2003-11-20.
- Submission: K032935
- Applicant / Sponsor: Edx Epi-Scan, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1540
- Decision date: 2003-11-20
Classification & Regulation
This clearance is catalogued under FDA product code GZO and 21 CFR 882.1540, within the Neurology review panel as a Class II device.