FDA 510(k) Application Details - K191307

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K191307
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	Mianyang Meike Electronic Equipment Co., Ltd. No. 63, Yinping Road, Longmen Town Fucheng District Mianyang 621000 CN Other 510(k) Applications for this Company
Contact	Wenjun Zhao 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	05/14/2019
Decision Date	06/05/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review