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510(k) K113785

ADHERENT VISUAL STIMULATOR GOGGLES by Anschel Technology, Inc. — Product Code GWE

K113785 is an FDA 510(k) premarket notification submitted by Anschel Technology, Inc. for the device "ADHERENT VISUAL STIMULATOR GOGGLES". The FDA issued a decision of Substantially Equivalent on June 6, 2012. The device falls under product code GWE (Stimulator, Photic, Evoked Response), a Class II device regulated under 21 CFR 882.1890.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2012
Date Received
December 23, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Photic, Evoked Response
Device Class
Class II
Regulation Number
882.1890
Review Panel
NE
Submission Type

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  • K173936 — Natus Photic Stimulator (June 15, 2018)
  • K142567 — RETeval Visual Electrodiagnostic Device (May 19, 2015)
  • K120104 — VISIONSEARCH 1 (May 21, 2012)
  • K101763 — DIOPSYS NOVA VEP VISION TESTING SYSTEM (May 9, 2011)
  • K101691 — LIFELINES PHOTIC STIMULATOR (August 10, 2010)

FDA data resources