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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name standard polysomnograph with electroencephalograph
510(k) Number K000338
Device Name VITAPORT 3
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 Number882.1400
Classification Product Code
OLV  
Subsequent Product Code
GWQ  
Date Received02/03/2000
Decision Date 04/26/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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