MODIFICATION TO EDI VERIS SYSTEM— 510(k) K003442

Name: FDA 510(k) clearance K003442
Creator: U.S. Food and Drug Administration
Published: 2001-05-04

Substantially Equivalent

Electro-Diagnostic Imaging, Inc.

FDA 510(k) clearance K003442 for MODIFICATION TO EDI VERIS SYSTEM, Substantially Equivalent on 2001-05-04. Applicant: Electro-Diagnostic Imaging, Inc.. Device class: 2.

Clearance details

Applicant: Electro-Diagnostic Imaging, Inc.
Product code: Code HLX
Device class: Class 2
Regulation: 21 CFR 886.1630
Advisory panel: Ophthalmic
Date received: 2000-11-06
Decision date: 2001-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Altos, CA, US

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