FDA 510(k) Application Details - K151070

Device Classification Name	Media,Coupling,Ultrasound   More FDA Info for this Device
510(K) Number	K151070
Device Name	Media,Coupling,Ultrasound
Applicant	Quotient Medical 3365 Harvester Road, Suite 110 Burlington L7N 3N2 CA Other 510(k) Applications for this Company
Contact	David Okamoto Other 510(k) Applications for this Contact
Regulation Number	892.1570   More FDA Info for this Regulation Number
Classification Product Code	MUI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/21/2015
Decision Date	01/13/2016
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