ICS Impulse— 510(k) K151504

Substantially Equivalent

Gn Otometrics

FDA 510(k) clearance K151504 for ICS Impulse, Substantially Equivalent on 2015-11-16. Applicant: Gn Otometrics. Device class: 2.

Clearance details

Applicant: Gn Otometrics
Product code: Code GWN
Device class: Class 2
Regulation: 21 CFR 882.1460
Advisory panel: Neurology
Date received: 2015-06-04
Decision date: 2015-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taastrup, DK

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

K161707 — Madsen Zodiac2016-09-01
K132957 — MADSEN ACCUSCREEN TYPE 10772014-02-27
K122550 — ICS IMPULSE2013-02-01
K122028 — AURICAL HIT2012-10-23
K122067 — TYPE 1077 ACCUSCREEN2012-09-27

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