Clearance Summary
EPI-SCAN SELECTIVE TISSUE CONDUCTANCE METER received FDA 510(k) clearance under submission number K874850, sponsored by Epi-Scan Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1988-05-20.
- Submission: K874850
- Applicant / Sponsor: Epi-Scan Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1540
- Decision date: 1988-05-20
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.