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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name amplitude-integrated electroencephalograph
510(k) Number K130238
Device Name NIHON KOHDEN AE-918P NEURO UNIT
Applicant
NIHON KOHDEN CORP.
13721 VIA TRES VISTA
SAN DIEGO,  CA  92129
Applicant Contact NATALIE KENNEL
Correspondent
NIHON KOHDEN CORP.
13721 VIA TRES VISTA
SAN DIEGO,  CA  92129
Correspondent Contact NATALIE KENNEL
Regulation Number882.1400
Classification Product Code
OMA  
Subsequent Product Codes
OLT   OMC  
Date Received01/31/2013
Decision Date 03/04/2015
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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