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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 K014255
Device Name DINAMAP PROCARE SERIES MONITOR; MODEL 100, 200, 300, 400
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 Received12/26/2001
Decision Date 07/02/2002
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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