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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name oximeter
510(k) Number K022193
Device Name DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N
Original Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
4502 woodland corp.blvd.
tampa,  FL  33614
Original Contact melissa robinson
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
MWI  
Date Received07/05/2002
Decision Date 08/01/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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