Cleared Traditional

INTEGRITY, MODEL V500

K043396 · Vivosonic, Inc. · Neurology
Jan 2005
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K043396 is an FDA 510(k) clearance for the INTEGRITY, MODEL V500, 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 January 24, 2005, 45 days after receiving the submission on December 10, 2004. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number K043396 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 2004
Decision Date January 24, 2005
Days to Decision 45 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