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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 K840439
Device Name RECOMED CARDIAC OUTPUT METER 236067-
Applicant
Litton Medical Electronics
777 Nicholas Blvd.
Elk Grove Village,  IL  60007
Applicant Contact ROBERT L CASARSA
Correspondent
Litton Medical Electronics
777 Nicholas Blvd.
Elk Grove Village,  IL  60007
Correspondent Contact ROBERT L CASARSA
Regulation Number870.1435
Classification Product Code
DXG  
Date Received02/01/1984
Decision Date 11/20/1984
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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