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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 K161902
Device Name Meridian M110 Fetal Monitoring System
Applicant
MINDCHILD MEDICAL
1600 OSGOOD STREET #2-17
NORTH ANDOVER,  MA  01845
Applicant Contact JIM ROBERTSON
Correspondent
NORTHSTAR BIOMEDICAL ASSOCIATES
93 BENEFIT STREET
PROVIDENCE,  RI  02904
Correspondent Contact LEO BASTA
Regulation Number884.2740
Classification Product Code
HGM  
Date Received07/11/2016
Decision Date 01/12/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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