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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K843287
Device Name ARRHYTHMIA CENTRAL OCC-7101
Applicant
Nihon Kohden America, Inc.
1652 Deere Ave.
Irvine,  CA  92714
Applicant Contact PAUL M PARASHAK
Correspondent
Nihon Kohden America, Inc.
1652 Deere Ave.
Irvine,  CA  92714
Correspondent Contact PAUL M PARASHAK
Regulation Number870.1025
Classification Product Code
DSI  
Date Received08/21/1984
Decision Date 10/18/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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