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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 K032252
Device Name MODEL 120 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 Received07/22/2003
Decision Date 08/21/2003
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
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