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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K111687
Device Name EMG SYSTEM
Applicant
MYOTRONICS-NOROMED, INC.
5870 S. 194TH ST.
KENT,  WA  98032 -2126
Applicant Contact F. ADIB
Correspondent
MYOTRONICS-NOROMED, INC.
5870 S. 194TH ST.
KENT,  WA  98032 -2126
Correspondent Contact F. ADIB
Regulation Number882.5050
Classification Product Code
HCC  
Date Received06/16/2011
Decision Date 09/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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