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510(k) K081591

NEUCODIA by Verisci Corporation — Product Code GWE

K081591 is an FDA 510(k) premarket notification submitted by Verisci Corporation for the device "NEUCODIA". The FDA issued a decision of Substantially Equivalent on May 15, 2009. 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
May 15, 2009
Date Received
June 6, 2008
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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  • K142567 — RETeval Visual Electrodiagnostic Device (May 19, 2015)
  • K113785 — ADHERENT VISUAL STIMULATOR GOGGLES (June 6, 2012)
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FDA data resources