DIOPSYS NOVA VEP VISION TESTING SYSTEM— 510(k) K101763

Name: FDA 510(k) clearance K101763
Creator: U.S. Food and Drug Administration
Published: 2011-05-09

Substantially Equivalent

Diopsys, Inc.

FDA 510(k) clearance K101763 for DIOPSYS NOVA VEP VISION TESTING SYSTEM, Substantially Equivalent on 2011-05-09. Applicant: Diopsys, Inc.. Device class: 2.

Clearance details

Applicant: Diopsys, Inc.
Product code: Code GWE
Device class: Class 2
Regulation: 21 CFR 882.1890
Advisory panel: Neurology
Date received: 2010-06-23
Decision date: 2011-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pine Brook, NJ, US

Download summary PDF View on FDA.gov ↗

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