FDA 510(k) Application Details - K232493

Device Classification Name	Accessory, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K232493
Device Name	Accessory, Assisted Reproduction
Applicant	Wuhan Huchuang Union Technology Co., Ltd. Building 10, No.818 Gaoxin Avenue Wuhan 430206 CN Other 510(k) Applications for this Company
Contact	Yuanyuan Zhan Other 510(k) Applications for this Contact
Regulation Number	884.6120   More FDA Info for this Regulation Number
Classification Product Code	MQG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/17/2023
Decision Date	05/07/2024
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