FDA 510(k) Application Details - K131905

Device Classification Name	Media,Coupling,Ultrasound   More FDA Info for this Device
510(K) Number	K131905
Device Name	Media,Coupling,Ultrasound
Applicant	BLUEMTECH 1515 E KATELLA AVE UNIT 2115 ANAHEIM, CA 92805 US Other 510(k) Applications for this Company
Contact	Priscilla Chung 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	06/26/2013
Decision Date	07/18/2013
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