Cleared Traditional

EDI VERIS SYSTEM

K983983 · Electro-Diagnostic Imaging, Inc. · Ophthalmic

Feb 1999

Decision

86d

Days

Class 2

Risk

About This 510(k) Submission

K983983 is an FDA 510(k) clearance for the 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 February 3, 1999, 86 days after receiving the submission on November 9, 1998. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1630.

Submission Details

510(k) Number	K983983 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 09, 1998
Decision Date	February 03, 1999
Days to Decision	86 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF