Cleared Traditional

MYOVISION 3.0 WIREFREE SYSTEM

K123399 · Precision Biometrics, Inc. · Neurology
Aug 2013
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K123399 is an FDA 510(k) clearance for the MYOVISION 3.0 WIREFREE SYSTEM, a Electromyograph, Diagnostic (Class II — Special Controls, product code IKN), submitted by Precision Biometrics, Inc. (Seattle, US). The FDA issued a Cleared decision on August 1, 2013, 269 days after receiving the submission on November 5, 2012. This device falls under the Neurology review panel. Regulated under 21 CFR 890.1375.

Submission Details

510(k) Number K123399 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 2012
Decision Date August 01, 2013
Days to Decision 269 days
Submission Type Traditional
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