FDA 510(k) Application Details - K142769

Device Classification Name	Monitor, Heart Sound, Fetal, Ultrasonic   More FDA Info for this Device
510(K) Number	K142769
Device Name	Monitor, Heart Sound, Fetal, Ultrasonic
Applicant	iCare Newlife Technologies, Inc. Wangjing Science Pioneer Park, Suite E-510A, Chaoyang Beijing 100102 CN Other 510(k) Applications for this Company
Contact	BO XIAO Other 510(k) Applications for this Contact
Regulation Number	884.2660   More FDA Info for this Regulation Number
Classification Product Code	HEK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2014
Decision Date	03/20/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review