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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 K852076
Device Name MODEL 145 FETAL MONITOR
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 Received05/13/1985
Decision Date 07/05/1985
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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