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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Monitoring, Perinatal
510(k) Number K050583
Device Name MODEL 250 SERIES MATERNAL/FETAL MONITOR
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
4502 WOODLAND CORPORATE BLVD.
TAMPA,  FL  33614
Applicant Contact MELISSA ROBINSON
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
4502 WOODLAND CORPORATE BLVD.
TAMPA,  FL  33614
Correspondent Contact MELISSA ROBINSON
Regulation Number884.2740
Classification Product Code
HGM  
Date Received03/07/2005
Decision Date 06/21/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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