FDA 510(k) Application Details - K212084

Device Classification Name	Monitor, Ultrasonic, Fetal   More FDA Info for this Device
510(K) Number	K212084
Device Name	Monitor, Ultrasonic, Fetal
Applicant	Shenzhen Mericonn Technology Co., Ltd. Room 20203, Building 6, Donglongxing Kejiyuan, Huaning Road, Xinshishequ, Dalang Street Shenzhen 518109 CN Other 510(k) Applications for this Company
Contact	Jiang Chuanyuan 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	07/02/2021
Decision Date	11/03/2021
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