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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 K120018
Device Name MINDCHILD MERIDIAN FETAL HEART RATE MONITOR
Applicant
MINDCHILD MEDICAL
755 WESTMINSTER STREET
UNIT 120
PROVIDENCE,  RI  02903
Applicant Contact LEO BASTA
Correspondent
MINDCHILD MEDICAL
755 WESTMINSTER STREET
UNIT 120
PROVIDENCE,  RI  02903
Correspondent Contact LEO BASTA
Regulation Number884.2740
Classification Product Code
HGM  
Date Received01/03/2012
Decision Date 09/19/2012
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
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