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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 K991739
Device Name COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
Applicant
General Electric Medical Systems Information Techn
200 Harry S. Truman Pkwy.
Suite 220
Annapolis,  MD  21401
Applicant Contact MARIA VITUG FOUTS
Correspondent
General Electric Medical Systems Information Techn
200 Harry S. Truman Pkwy.
Suite 220
Annapolis,  MD  21401
Correspondent Contact MARIA VITUG FOUTS
Regulation Number884.2740
Classification Product Code
HGM  
Date Received05/21/1999
Decision Date 08/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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