2D VOG - VIDEO-OCULOGRAPHY— 510(k) K972243

Name: FDA 510(k) clearance K972243
Creator: U.S. Food and Drug Administration
Published: 1997-09-10

Substantially Equivalent

Sensomotoric Instruments, GmbH

FDA 510(k) clearance K972243 for 2D VOG - VIDEO-OCULOGRAPHY, Substantially Equivalent on 1997-09-10. Applicant: Sensomotoric Instruments, GmbH. Device class: 2.

Clearance details

Applicant: Sensomotoric Instruments, GmbH
Product code: Code GWN
Device class: Class 2
Regulation: 21 CFR 882.1460
Advisory panel: Neurology
Date received: 1997-06-16
Decision date: 1997-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Teltow, DE

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.