Cleared Special

MODEL MES-9000/EMG SYSTEM

K013399 · Myotronics-Noromed, Inc. · Neurology
Nov 2001
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K013399 is an FDA 510(k) clearance for the MODEL MES-9000/EMG SYSTEM, a Device, Biofeedback (Class II — Special Controls, product code HCC), submitted by Myotronics-Noromed, Inc. (Tukwila, US). The FDA issued a Cleared decision on November 13, 2001, 29 days after receiving the submission on October 15, 2001. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5050.

Submission Details

510(k) Number K013399 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 2001
Decision Date November 13, 2001
Days to Decision 29 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