NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM— 510(k) K130201

Name: FDA 510(k) clearance K130201
Creator: U.S. Food and Drug Administration
Published: 2013-04-26

Substantially Equivalent

Ototronix, LLC

FDA 510(k) clearance K130201 for NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM, Substantially Equivalent on 2013-04-26. Applicant: Ototronix, LLC. Device class: 2.

Clearance details

Applicant: Ototronix, LLC
Product code: Code GWN
Device class: Class 2
Regulation: 21 CFR 882.1460
Advisory panel: Neurology
Date received: 2013-01-28
Decision date: 2013-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, 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

More clearances from Ototronix, LLC

view all

K140644 — PROCEM2014-06-19

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