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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electromyograph, diagnostic
510(k) Number K123399
Device Name MYOVISION 3.0 WIREFREE SYSTEM
Applicant
PRECISION BIOMETRICS, INC.
2303 W Commodore Way Ste 301
Seattle,  WA  98199
Applicant Contact ERIC CHEN
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number890.1375
Classification Product Code
IKN  
Subsequent Product Codes
HCC   HCS   KQX  
Date Received11/05/2012
Decision Date 08/01/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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