Cleared Traditional

K072254 - VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM
(FDA 510(k) Clearance)

K072254 · Interacoustics A/S · Neurology
Feb 2008
Decision
175d
Days
Class 2
Risk

K072254 is an FDA 510(k) clearance for the VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM, a Nystagmograph (Class II — Special Controls, product code GWN), submitted by Interacoustics A/S (Minnesota, US). The FDA issued a Cleared decision on February 5, 2008, 175 days after receiving the submission on August 14, 2007. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1460.

Submission Details

510(k) Number K072254 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2007
Decision Date February 05, 2008
Days to Decision 175 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