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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 K802305
Device Name MLC-4200 CARDIAC OUTPUT COMPUTER
Applicant
Nihon Kohden America, Inc.
90 Icon St.
Foothill,  CA  92610
Correspondent
Nihon Kohden America, Inc.
90 Icon St.
Foothill,  CA  92610
Regulation Number870.1435
Classification Product Code
DXG  
Date Received09/23/1980
Decision Date 10/10/1980
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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