FDA 510(k) Application Details - K170856

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K170856
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	Contec Medical Systems Co., LTD. No. 112 Qinhuang West Street Economic & Technical Development Zone Qinhuangdao 066004 CN Other 510(k) Applications for this Company
Contact	Xueyong Li Other 510(k) Applications for this Contact
Regulation Number	892.1560   More FDA Info for this Regulation Number
Classification Product Code	IYO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/22/2017
Decision Date	11/17/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review