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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 K132437
Device Name MARS HOLTER ANALYSIS WORKSTATION
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
9900 WEST INNOVATION DRIVE
WAUWATOSA,  WI  53226
Applicant Contact KRISTIN PABST
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
9900 WEST INNOVATION DRIVE
WAUWATOSA,  WI  53226
Correspondent Contact KRISTIN PABST
Regulation Number870.1425
Classification Product Code
DQK  
Date Received08/05/2013
Decision Date 12/04/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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