Cleared Traditional

ICS IMPULSE

K122550 · Gn Otometrics · Neurology
Feb 2013
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K122550 is an FDA 510(k) clearance for the ICS IMPULSE, a Nystagmograph (Class II — Special Controls, product code GWN), submitted by Gn Otometrics (Naples, US). The FDA issued a Cleared decision on February 1, 2013, 164 days after receiving the submission on August 21, 2012. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1460.

Submission Details

510(k) Number K122550 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2012
Decision Date February 01, 2013
Days to Decision 164 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