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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 K991899
Device Name NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES
Applicant
NIHON KOHDEN AMERICA, INC.
2601 CAMPUS DR.
IRVINE,  CA  92612 -1601
Applicant Contact BONNIE BISHOP
Correspondent
NIHON KOHDEN AMERICA, INC.
2601 CAMPUS DR.
IRVINE,  CA  92612 -1601
Correspondent Contact BONNIE BISHOP
Regulation Number882.1870
Classification Product Code
GWF  
Subsequent Product Codes
GWQ   GZO   IKN  
Date Received06/04/1999
Decision Date 09/01/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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