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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Muscle Monitoring
510(k) Number K830034
Device Name MODEL EM-2 BIOELECTRIC PROCESSOR
Applicant
Myo-Tronics Research, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Myo-Tronics Research, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.1375
Classification Product Code
KZM  
Date Received01/07/1983
Decision Date 02/09/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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