Adherent Visual Stimulator Goggles

FDA 510(k) K113785 · Anschel Technology, Inc.

Substantially Equivalent

510(k) numberK113785

Submission

Device name
Adherent Visual Stimulator Goggles
Applicant
Anschel Technology, Inc.
New York, NY, US
Received
December 23, 2011
Decision date
June 6, 2012
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 Adherent Visual Stimulator Goggles cleared by the FDA?

Adherent Visual Stimulator Goggles (K113785) received a 510(k) decision of Substantially Equivalent on June 6, 2012, 166 days after the submission was received.

What is the product code of K113785?

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