FDA 510(k) Application Details - K140579

Device Classification Name	Monitor, Ultrasonic, Fetal   More FDA Info for this Device
510(K) Number	K140579
Device Name	Monitor, Ultrasonic, Fetal
Applicant	EDAN INSTRUMENTS, INC. NANHAI RD 1019 NO. SHEKOU, NANSHAN SHENZHEN, GUANGDONG 518067 CN Other 510(k) Applications for this Company
Contact	QUEENA CHEN Other 510(k) Applications for this Contact
Regulation Number	884.2660   More FDA Info for this Regulation Number
Classification Product Code	KNG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/06/2014
Decision Date	02/06/2015
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