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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 K991905
Device Name COROMETRICS MODEL 171 AND 172 FETAL MONITOR
Applicant
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
61 BARNES PARK RD. NORTH
WALLINGFORD,  CT  06492 -0333
Applicant Contact RICHARD CEHOVSKY
Correspondent
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
61 BARNES PARK RD. NORTH
WALLINGFORD,  CT  06492 -0333
Correspondent Contact RICHARD CEHOVSKY
Regulation Number884.2740
Classification Product Code
HGM  
Date Received06/04/1999
Decision Date 09/01/1999
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
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