FDA 510(k) Application Details - K171178

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K171178
Device Name	System, Monitoring, Perinatal
Applicant	Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Shenzhen 518122 CN Other 510(k) Applications for this Company
Contact	Alice Yang Other 510(k) Applications for this Contact
Regulation Number	884.2740   More FDA Info for this Regulation Number
Classification Product Code	HGM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/21/2017
Decision Date	09/06/2017
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