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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 K063447
Device Name INSIGHT DISCOVERY
Applicant
FASSTECH
76 TREBLE COVE RD.
BUILDING #2
NORTH BILLERICA,  MA  01862
Applicant Contact LEE BRODY
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact NEIL E DEVINE, JR.
Regulation Number890.1375
Classification Product Code
IKN  
Subsequent Product Code
HCC  
Date Received11/15/2006
Decision Date 08/16/2007
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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