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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
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