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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 K012718
Device Name MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
Applicant
Ge Medical Systems Information Technologies
61 Barnes Park Rd. N.
Wallingford,  CT  06492
Applicant Contact JOELLE NEIDER
Correspondent
Ge Medical Systems Information Technologies
61 Barnes Park Rd. N.
Wallingford,  CT  06492
Correspondent Contact JOELLE NEIDER
Regulation Number884.2740
Classification Product Code
HGM  
Date Received08/15/2001
Decision Date 11/13/2001
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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