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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 K843918
Device Name COROMETRICS FETAL MONITOR 142
Applicant
Ge Medical Systems Information Technologies
P.O. Box 333
Wallingford,  CT  06492 -
Applicant Contact JOSEPH P LENZEN
Correspondent
Ge Medical Systems Information Technologies
P.O. Box 333
Wallingford,  CT  06492 -
Correspondent Contact JOSEPH P LENZEN
Regulation Number884.2740
Classification Product Code
HGM  
Date Received10/05/1984
Decision Date 12/17/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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