Cleared Traditional

VIVOSONIC NEUROSCREEN

K080060 · Vivosonic, Inc. · Neurology
Apr 2008
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K080060 is an FDA 510(k) clearance for the VIVOSONIC NEUROSCREEN, a Stimulator, Auditory, Evoked Response (Class II — Special Controls, product code GWJ), submitted by Vivosonic, Inc. (Toronto, On, CA). The FDA issued a Cleared decision on April 4, 2008, 86 days after receiving the submission on January 9, 2008. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number K080060 FDA.gov
FDA Decision Cleared SESE
Date Received January 09, 2008
Decision Date April 04, 2008
Days to Decision 86 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code GWJ — Stimulator, Auditory, Evoked Response
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1900