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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 K992694
Device Name MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I
Applicant
Myotronics-Noromed, Inc.
15425 53rd Ave. S.
Tukwila,  WA  98188
Applicant Contact FRAY ADIB
Correspondent
Myotronics-Noromed, Inc.
15425 53rd Ave. S.
Tukwila,  WA  98188
Correspondent Contact FRAY ADIB
Regulation Number890.1375
Classification Product Code
KZM  
Subsequent Product Code
IKN  
Date Received08/12/1999
Decision Date 09/10/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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