FDA 510(k) Application Details - K242684

Device Classification Name	Accessory, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K242684
Device Name	Accessory, Assisted Reproduction
Applicant	Hua Yue Medical Technology Co., Ltd. First Floor, C2 building, No.11 Kaiyuan Road Huangpu District, Guangzhou City, Guangdong Province Guangzhou 510530 CN Other 510(k) Applications for this Company
Contact	Zhenzhi Shi 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	09/06/2024
Decision Date	05/22/2025
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