FDA 510(k) Application Details - K242043

Device Classification Name	Media, Reproductive   More FDA Info for this Device
510(K) Number	K242043
Device Name	Media, Reproductive
Applicant	Gimbo Medical Technology Shenzhen Co., Ltd. 601, Building C5, No. 459 Qiaokai Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Province Shenzhen 518107 CN Other 510(k) Applications for this Company
Contact	Leo Guo Other 510(k) Applications for this Contact
Regulation Number	884.6180   More FDA Info for this Regulation Number
Classification Product Code	MQL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/12/2024
Decision Date	01/08/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review