Cleared Traditional

TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4

K932571 · Tomey Corporation USA · Neurology
Aug 1995
Decision
826d
Days
Class 2
Risk

About This 510(k) Submission

K932571 is an FDA 510(k) clearance for the TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4, a Stimulator, Photic, Evoked Response (Class II — Special Controls, product code GWE), submitted by Tomey Corporation USA (Cambridge, US). The FDA issued a Cleared decision on August 31, 1995, 826 days after receiving the submission on May 27, 1993. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1890.

Submission Details

510(k) Number K932571 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 1993
Decision Date August 31, 1995
Days to Decision 826 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code GWE — Stimulator, Photic, Evoked Response
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1890