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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 K120397
Device Name MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM
Applicant
NIHON KOHDEN CORP.
90 ICON STREET
FOOTHILL RANCH,  CA  92610
Applicant Contact STEVE GEERDES
Correspondent
NIHON KOHDEN CORP.
90 ICON STREET
FOOTHILL RANCH,  CA  92610
Correspondent Contact STEVE GEERDES
Regulation Number882.1870
Classification Product Code
GWF  
Subsequent Product Codes
GWE   GWJ   GWQ   GZO   IKN  
Date Received02/08/2012
Decision Date 09/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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