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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K102106
Device Name NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION
Applicant
Nihon Kohden Corp.
90 Icon St.
Foothill,  CA  92610
Applicant Contact STEVE GEERDES
Correspondent
Nihon Kohden Corp.
90 Icon St.
Foothill,  CA  92610
Correspondent Contact STEVE GEERDES
Regulation Number870.2910
Classification Product Code
DRG  
Date Received07/27/2010
Decision Date 12/17/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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