Clearance Summary
TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4 received FDA 510(k) clearance under submission number K932571, sponsored by Tomey Corporation USA. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1995-08-31.
- Submission: K932571
- Applicant / Sponsor: Tomey Corporation USA
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1890
- Decision date: 1995-08-31
Classification & Regulation
This clearance is catalogued under FDA product code GWE and 21 CFR 882.1890, within the Neurology review panel as a Class II device.