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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 (Without Arrhythmia Detection Or Alarms)
510(k) Number K020022
Device Name DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410
Applicant
Ge Medical Systems Information Technologies
4502 Woodland Corp.Blvd.
Tampa,  FL  33614
Applicant Contact THOMAS ENGLISH
Correspondent
Ge Medical Systems Information Technologies
4502 Woodland Corp.Blvd.
Tampa,  FL  33614
Correspondent Contact THOMAS ENGLISH
Regulation Number870.2300
Classification Product Code
MWI  
Date Received01/03/2002
Decision Date 02/01/2002
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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