HOUSE INFRARED/VIDEO ELECTRONYSTAGMOGRAPH SYSTEM— 510(k) K925111

Name: FDA 510(k) clearance K925111
Creator: U.S. Food and Drug Administration
Published: 1994-03-23

Substantially Equivalent

Eye Dynamics, Inc.

FDA 510(k) clearance K925111 for HOUSE INFRARED/VIDEO ELECTRONYSTAGMOGRAPH SYSTEM, Substantially Equivalent on 1994-03-23. Applicant: Eye Dynamics, Inc.. Device class: 2.

Clearance details

Applicant: Eye Dynamics, Inc.
Product code: Code GWN
Device class: Class 2
Regulation: 21 CFR 882.1460
Advisory panel: Neurology
Date received: 1992-10-09
Decision date: 1994-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Torrance, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWN

view all

K260566 — SMARTVERTIGO Vestibular Assessment System2026-07-30
K243709 — NeuroEars-Anna2025-08-25
K242198 — ICS Dizcovery (1091)2025-02-14
K242726 — Synapsys VHIT2025-01-03
K223047 — NeuroSwift Pro2023-06-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.