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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 K042148
Device Name HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES
Applicant
GE MEDICAL SYST. INFORMATION TECHNOLOGIES
8200 WEST TOWER AVE.
MILWAUKEE,  WI  53223
Applicant Contact LISA M BAUMHARDT
Correspondent
GE MEDICAL SYST. INFORMATION TECHNOLOGIES
8200 WEST TOWER AVE.
MILWAUKEE,  WI  53223
Correspondent Contact LISA M BAUMHARDT
Regulation Number870.1425
Classification Product Code
DQK  
Date Received08/09/2004
Decision Date 12/03/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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