FDA 510(k) Application Details - K232893

Device Classification Name	Monitor, Ultrasonic, Fetal   More FDA Info for this Device
510(K) Number	K232893
Device Name	Monitor, Ultrasonic, Fetal
Applicant	Contec Medical Systems Co., Ltd. No.112 Qinhuang West Street, Economic &Technical Development Zone Qinhuangdao 066004 CN Other 510(k) Applications for this Company
Contact	Jie Xiao 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	09/18/2023
Decision Date	06/14/2024
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