Home / 510(k) Clearances / K130201

510(k) K130201

NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM by Ototronix, LLC — Product Code GWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2013
Date Received
January 28, 2013
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 Ototronix, LLC

  • K140644 — PROCEM (June 19, 2014)

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)