Home / 510(k) Clearances / K101691

510(k) K101691

LIFELINES PHOTIC STIMULATOR by Lifelines , Ltd. — Product Code GWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2010
Date Received
June 16, 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 Lifelines , Ltd.

  • K172271 — Trackit T4 EEG Amplifier (May 4, 2018)
  • K151600 — R-40 EEG Amplifier (October 23, 2015)
  • K010460 — LIFELINES TRACKIT (May 14, 2001)

Other clearances for product code GWE

  • K221471 — E3 and Profile (November 22, 2022)
  • K212936 — Vision Monitor- MonCvONE (November 21, 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)