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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Pre-Programmed, Single-Function
510(k) Number K792678
Device Name CARDIAC OUTPUT COMPUTER, M-MLC-4100
Applicant
Nihon Kohden America, Inc.
90 Icon St.
Foothill Ranch,  CA  92610 -1601
Correspondent
Nihon Kohden America, Inc.
90 Icon St.
Foothill Ranch,  CA  92610 -1601
Regulation Number870.1435
Classification Product Code
DXG  
Date Received12/26/1979
Decision Date 01/09/1980
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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