Home / 510(k) Clearances / K964325

510(k) K964325

VISUALEYES: VIDEO EYE MONITOR by Micromedical Technologies, Inc. — Product Code GWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1997
Date Received
October 30, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nystagmograph
Device Class
Class II
Regulation Number
882.1460
Review Panel
NE
Submission Type

Other clearances by Micromedical Technologies, Inc.

  • K964646 — VIDEO EYE TRAKKER (July 15, 1997)
  • K922037 — SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR (October 26, 1992)
  • K891008 — VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ) (May 31, 1989)
  • K863424 — COMPUTER EYE TRACKING SYS./ENG EXAM. CHAIR & TABLE (March 23, 1987)

Other clearances for product code GWN

  • K243709 — NeuroEars-Anna™ (August 25, 2025)
  • K242198 — ICS Dizcovery (1091) (February 14, 2025)
  • K242726 — Synapsys VHIT (January 3, 2025)
  • K223047 — NeuroSwift Pro (June 29, 2023)
  • K203082 — Insight Infrared Video Goggles (November 12, 2020)
  • K200534 — VisualEyes (August 12, 2020)
  • K192186 — I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Por (November 29, 2019)
  • K181771 — RightEye Vision System (September 28, 2018)
  • K182214 — DizzyDoctor System 1.0.0 (September 14, 2018)
  • K181025 — I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Por (July 24, 2018)