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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 K841500
Device Name LIFESCOPE 6 OEC-6201
Applicant
Nihon Kohden America, Inc.
90 Icon St.
Foothill,  CA  92610
Correspondent
Nihon Kohden America, Inc.
90 Icon St.
Foothill,  CA  92610
Regulation Number870.1025
Classification Product Code
DSI  
Date Received04/10/1984
Decision Date 08/28/1984
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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