Cleared Traditional

ICS Impulse

K151504 · Gn Otometrics · Neurology
Nov 2015
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K151504 is an FDA 510(k) clearance for the ICS Impulse, a Nystagmograph (Class II — Special Controls, product code GWN), submitted by Gn Otometrics (Taastrup, DK). The FDA issued a Cleared decision on November 16, 2015, 165 days after receiving the submission on June 4, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1460.

Submission Details

510(k) Number K151504 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2015
Decision Date November 16, 2015
Days to Decision 165 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWN — Nystagmograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1460