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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 K053121
Device Name TRAM MODULE
Applicant
GE HEALTHCARE
86 PILGRIM ROAD
NEEDHAM,  MA  02492
Applicant Contact JOEL KENT
Correspondent
GE HEALTHCARE
86 PILGRIM ROAD
NEEDHAM,  MA  02492
Correspondent Contact JOEL KENT
Regulation Number870.1025
Classification Product Code
MHX  
Date Received11/07/2005
Decision Date 04/05/2006
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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