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510(k) K212936

Vision Monitor- MonCvONE by Metrovision — Product Code GWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2022
Date Received
September 15, 2021
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 Metrovision

  • K211643 — Vision Monitor - MonpackONE (July 26, 2021)

Other clearances for product code GWE

  • K221471 — E3 and Profile (November 22, 2022)
  • 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)
  • K101763 — DIOPSYS NOVA VEP VISION TESTING SYSTEM (May 9, 2011)
  • K101691 — LIFELINES PHOTIC STIMULATOR (August 10, 2010)