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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K102376
Device Name NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201
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 Number870.1025
Classification Product Code
MHX  
Date Received08/20/2010
Decision Date 12/07/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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