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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 K922456
Device Name K6-I DIAGNOSTIC SYSTEM
Applicant
Myo-Tronics, Inc.
720 Olive Way Suite 800
Seattle,  WA  98101
Applicant Contact ADIB
Correspondent
Myo-Tronics, Inc.
720 Olive Way Suite 800
Seattle,  WA  98101
Correspondent Contact ADIB
Regulation Number890.1375
Classification Product Code
KZM  
Subsequent Product Code
NFS  
Date Received05/26/1992
Decision Date 06/09/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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