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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 K831852
Device Name FETAL MONITOR #115
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.2740
Classification Product Code
HGM  
Date Received06/09/1983
Decision Date 08/11/1983
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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