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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 K944134
Device Name K6-1 DIAGNOSTIC SYSTEM VERSION 3.1
Applicant
Myo-Tronics, Inc.
15425 - 33rd Ave. S.
Tukwila,  WA  98188
Applicant Contact FRAY ADIB
Correspondent
Myo-Tronics, Inc.
15425 - 33rd Ave. S.
Tukwila,  WA  98188
Correspondent Contact FRAY ADIB
Regulation Number890.1375
Classification Product Code
KZM  
Subsequent Product Code
NFS  
Date Received08/24/1994
Decision Date 12/09/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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