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510(k) K101763

DIOPSYS NOVA VEP VISION TESTING SYSTEM by Diopsys, Inc. — Product Code GWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2011
Date Received
June 23, 2010
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

Other clearances by Diopsys, Inc.

  • K043491 — ENFANTTM (March 16, 2005)

Other clearances for product code GWE

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  • K211974 — LED PHOTIC System (September 23, 2021)
  • K211643 — Vision Monitor - MonpackONE (July 26, 2021)
  • K200705 — Nurochek System (April 23, 2020)
  • K173936 — Natus Photic Stimulator (June 15, 2018)
  • K142567 — RETeval Visual Electrodiagnostic Device (May 19, 2015)
  • K113785 — ADHERENT VISUAL STIMULATOR GOGGLES (June 6, 2012)
  • K120104 — VISIONSEARCH 1 (May 21, 2012)
  • K101691 — LIFELINES PHOTIC STIMULATOR (August 10, 2010)