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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 K073462
Device Name MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES
Applicant
Ge Medical Systems Information Technologies
86 Pilgrin Rd.
Needham,  MA  02492
Applicant Contact JOEL KENT
Correspondent
Ge Medical Systems Information Technologies
86 Pilgrin Rd.
Needham,  MA  02492
Correspondent Contact JOEL KENT
Regulation Number870.1025
Classification Product Code
MHX  
Date Received12/10/2007
Decision Date 01/11/2008
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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