FDA 510(k) Application Details - K180073

Device Classification Name	Media, Reproductive   More FDA Info for this Device
510(K) Number	K180073
Device Name	Media, Reproductive
Applicant	Shenzhen Vitavitro Bio-tech Co., Ltd R601, Building B, Hai Ke Xing Tech Park Baoshan Road No. 16 Shenzhen 518118 CN Other 510(k) Applications for this Company
Contact	Jenny Lin 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	01/09/2018
Decision Date	08/29/2018
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