Diopsys Nova Vep Vision Testing System

FDA 510(k) K101763 · Diopsys, Inc.

Substantially Equivalent

510(k) numberK101763

Submission

Device name
Diopsys Nova Vep Vision Testing System
Applicant
Diopsys, Inc.
Pine Brook, NJ, US
Received
June 23, 2010
Decision date
May 9, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GWE – Stimulator, Photic, Evoked Response
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1890
Specialty
Neurology

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Questions and answers

When was Diopsys Nova Vep Vision Testing System cleared by the FDA?

Diopsys Nova Vep Vision Testing System (K101763) received a 510(k) decision of Substantially Equivalent on May 9, 2011, 320 days after the submission was received.

What is the product code of K101763?

The FDA product code is GWE – Stimulator, Photic, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1890.