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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 K921919
Device Name MS-100 MYO-SCANNER OR MS-100 EMG SCANNER
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  
Date Received04/23/1992
Decision Date 01/07/1993
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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