Cleared Traditional

MODIFICATION TO EDI VERIS SYSTEM

K003442 · Electro-Diagnostic Imaging, Inc. · Ophthalmic

May 2001

Decision

179d

Days

Class 2

Risk

About This 510(k) Submission

K003442 is an FDA 510(k) clearance for the MODIFICATION TO EDI VERIS SYSTEM, a Photostimulator, Ac-powered (Class II — Special Controls, product code HLX), submitted by Electro-Diagnostic Imaging, Inc. (Los Altos, US). The FDA issued a Cleared decision on May 4, 2001, 179 days after receiving the submission on November 6, 2000. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1630.

Submission Details

510(k) Number	K003442 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 06, 2000
Decision Date	May 04, 2001
Days to Decision	179 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF