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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 K844116
Device Name CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC
Applicant
Critikon Company, LLC
4110 George Rd.
P.O. Box 22800
Tampa,  FL  33630
Applicant Contact MELANIE SABO
Correspondent
Critikon Company, LLC
4110 George Rd.
P.O. Box 22800
Tampa,  FL  33630
Correspondent Contact MELANIE SABO
Regulation Number870.1435
Classification Product Code
DXG  
Date Received10/23/1984
Decision Date 05/28/1985
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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