FDA 510(k) Application Details - K180419

Device Classification Name	Monitor, Ultrasonic, Fetal   More FDA Info for this Device
510(K) Number	K180419
Device Name	Monitor, Ultrasonic, Fetal
Applicant	Shenzhen IMDK Medical Technology Co., Ltd. C Zone, 10F, Building16, Yuanshan Industrial B Area Gongming Street, Guangming Shenzhen 518106 CN Other 510(k) Applications for this Company
Contact	Yuan Xia Other 510(k) Applications for this Contact
Regulation Number	884.2660   More FDA Info for this Regulation Number
Classification Product Code	KNG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/15/2018
Decision Date	07/19/2018
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