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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K031930
Device Name HIGH SPEED EMG MODULE
Applicant
Medical Measurement Systems B.V.
Colosseum 25
Enschede Overijssel,  NL 7521 PV
Applicant Contact KARIN OGINK-SOMHORST
Correspondent
Medical Measurement Systems B.V.
Colosseum 25
Enschede Overijssel,  NL 7521 PV
Correspondent Contact KARIN OGINK-SOMHORST
Regulation Number882.1870
Classification Product Code
GWF  
Subsequent Product Codes
FEN   JXE  
Date Received06/23/2003
Decision Date 03/03/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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