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510(k) K211974

LED PHOTIC System by Micromed S.P.A. — Product Code GWE

K211974 is an FDA 510(k) premarket notification submitted by Micromed S.P.A. for the device "LED PHOTIC System". The FDA issued a decision of Substantially Equivalent on September 23, 2021. The device falls under product code GWE (Stimulator, Photic, Evoked Response), a Class II device regulated under 21 CFR 882.1890. Micromed S.P.A. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2021
Date Received
June 25, 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 Micromed S.P.A.

  • K180761 — SD LTM STIM Cortical Stimulator (June 18, 2018)
  • K171384 — Micromed BRAIN QUICK system (February 1, 2018)
  • K071782 — MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES (January 10, 2008)
  • K914762 — MICRO MED INC. QRS-CARD(TM) OFFICE ECG MONITOR (December 5, 1991)
  • K882980 — REBUILDER BUCKET SYSTEM (April 24, 1989)
  • K874085 — REBUILDER(TM) (December 11, 1987)

Other clearances for product code GWE

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

FDA data resources