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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 K151080
Device Name Nihon Kohden CSM 1901 Bedside Monitor
Applicant
Nihon Kohden
15353 Barranca Pkwy.
Rvine,  CA  92618
Applicant Contact Tom Bento
Correspondent
Certified Compliance Solutions, Inc.
11665 Avena Place Suite 203
San Diego,  CA  92128
Correspondent Contact Al Pacheco
Regulation Number870.1025
Classification Product Code
MHX  
Date Received04/22/2015
Decision Date 11/05/2015
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
Recalls CDRH Recalls
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