FDA 510(k) Application Details - K240002

Device Classification Name	Labware, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K240002
Device Name	Labware, Assisted Reproduction
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	884.6160   More FDA Info for this Regulation Number
Classification Product Code	MQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/2024
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	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review