Cleared Special

ViMove2

K163150 · Dorsavi, Ltd. · Neurology
Jul 2017
Decision
247d
Days
Class 2
Risk

About This 510(k) Submission

K163150 is an FDA 510(k) clearance for the ViMove2, a Electromyograph, Diagnostic (Class II — Special Controls, product code IKN), submitted by Dorsavi, Ltd. (East Melbourne, AU). The FDA issued a Cleared decision on July 14, 2017, 247 days after receiving the submission on November 9, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 890.1375.

Submission Details

510(k) Number K163150 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 2016
Decision Date July 14, 2017
Days to Decision 247 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code IKN — Electromyograph, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.1375