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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 K851252
Device Name COROMETRICS 115 FETAL MONITOR W/DUAL CARDIOTACHOME
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
61 BARNES PARK RD., NORTH
WALLINGFORD,  CT  06492
Applicant Contact JOSEPH P LENZEN
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
61 BARNES PARK RD., NORTH
WALLINGFORD,  CT  06492
Correspondent Contact JOSEPH P LENZEN
Regulation Number884.2740
Classification Product Code
HGM  
Date Received03/27/1985
Decision Date 05/22/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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