FDA 510(k) Application Details - K182710

Device Classification Name	Monitor, Ultrasonic, Fetal   More FDA Info for this Device
510(K) Number	K182710
Device Name	Monitor, Ultrasonic, Fetal
Applicant	ShenzZhen Luckcome Technology Inc., Ltd. Floor 6A, 6th Building , Tongfuyu Industrial Park, Nanshan District Shenzhen 518055 CN Other 510(k) Applications for this Company
Contact	Can He 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	09/27/2018
Decision Date	03/01/2019
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