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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 K071058
Device Name MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A
Applicant
Nihon Kohden America, Inc.
90 Icon St.
Foothill,  CA  92610
Applicant Contact SERRAH NAMINI
Correspondent
Nihon Kohden America, Inc.
90 Icon St.
Foothill,  CA  92610
Correspondent Contact SERRAH NAMINI
Regulation Number870.2910
Classification Product Code
DRG  
Date Received04/16/2007
Decision Date 06/29/2007
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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