FDA 510(k) Application Details - K182460

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K182460
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	Meda Co., LTD F2C,F3D,F4C,F5, F6C, Bldg C2, Xinmao Science Skill Park, Huayuan Ind. Area Tianjin 300384 CN Other 510(k) Applications for this Company
Contact	Linda Zhang 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	09/10/2018
Decision Date	05/06/2019
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