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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K071073
Device Name SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8200 WEST TOWER AVE.
MILWAUKEE,  WI  53223
Applicant Contact KAREN M LUNDE
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8200 WEST TOWER AVE.
MILWAUKEE,  WI  53223
Correspondent Contact KAREN M LUNDE
Regulation Number870.1025
Classification Product Code
MHX  
Date Received04/16/2007
Decision Date 05/11/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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