Cleared Special

EMG SYSTEM

K111687 · Myotronics-Noromed, Inc. · Neurology
Sep 2011
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K111687 is an FDA 510(k) clearance for the EMG SYSTEM, a Device, Biofeedback (Class II — Special Controls, product code HCC), submitted by Myotronics-Noromed, Inc. (Kent, US). The FDA issued a Cleared decision on September 29, 2011, 105 days after receiving the submission on June 16, 2011. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5050.

Submission Details

510(k) Number K111687 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2011
Decision Date September 29, 2011
Days to Decision 105 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HCC — Device, Biofeedback
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5050