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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, programmable
510(k) Number K130626
Device Name MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
8200 WEST TOWER AVE.
MILWAUKEE,  WI  53223
Applicant Contact PHILIP MALCA
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
8200 WEST TOWER AVE.
MILWAUKEE,  WI  53223
Correspondent Contact PHILIP MALCA
Regulation Number870.1425
Classification Product Code
DQK  
Date Received03/08/2013
Decision Date 05/01/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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