FDA 510(k) Application Details - K161902

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K161902
Device Name	System, Monitoring, Perinatal
Applicant	MINDCHILD MEDICAL 1600 OSGOOD STREET #2-17 NORTH ANDOVER, MA 01845 US Other 510(k) Applications for this Company
Contact	JIM ROBERTSON Other 510(k) Applications for this Contact
Regulation Number	884.2740   More FDA Info for this Regulation Number
Classification Product Code	HGM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/11/2016
Decision Date	01/12/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review