FOCUS VNG/ENG TYPE 1068— 510(k) K061791

Substantially Equivalent

Gn Otometrics A/S

FDA 510(k) clearance K061791 for FOCUS VNG/ENG TYPE 1068, Substantially Equivalent on 2006-07-11. Applicant: Gn Otometrics A/S. Device class: 2.

Clearance details

Applicant: Gn Otometrics A/S
Product code: Code GWN
Device class: Class 2
Regulation: 21 CFR 882.1460
Advisory panel: Neurology
Date received: 2006-06-26
Decision date: 2006-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schaumburg, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWN

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 Gn Otometrics A/S

K143670 — ICS CHARTR EP 200 WITH VEMP2015-10-23
K110286 — GN OTOMETRICS TYPE 1053 FREEFIT2011-04-28
K083399 — ICS CHARTR EP 2002009-02-20
K061104 — SPEECHLINK 100 TYPE 10532006-05-03
K033645 — OTOFLEX 100 TYE 10122004-03-31

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