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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 K132528
Device Name E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES
Applicant
GE Healthcare Finland Oy
Kuortaneenkatu 2
Helsinki,  FI FIN-00510
Applicant Contact JOEL KENT
Correspondent
GE Healthcare Finland Oy
Kuortaneenkatu 2
Helsinki,  FI FIN-00510
Correspondent Contact JOEL KENT
Regulation Number870.1435
Classification Product Code
DXG  
Date Received08/12/2013
Decision Date 01/16/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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