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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 K022834
Device Name DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000
Applicant
Ge Medical Systems Information Technologies
4502 Woodland Corp.Blvd.
Tampa,  FL  33614
Applicant Contact MELISSA ROBINSON
Correspondent
Ge Medical Systems Information Technologies
4502 Woodland Corp.Blvd.
Tampa,  FL  33614
Correspondent Contact MELISSA ROBINSON
Regulation Number870.1025
Classification Product Code
MHX  
Date Received08/26/2002
Decision Date 05/13/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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