FDA 510(k) Application Details - K093393

Device Classification Name	Monitor, Ultrasonic, Nonfetal   More FDA Info for this Device
510(K) Number	K093393
Device Name	Monitor, Ultrasonic, Nonfetal
Applicant	SUMMIT DOPPLER SYSTEMS, INC. 4680 TABLE MOUNTAIN DR #150 GOLDEN, CO 80403 US Other 510(k) Applications for this Company
Contact	KEN JARRELL Other 510(k) Applications for this Contact
Regulation Number	892.1540   More FDA Info for this Regulation Number
Classification Product Code	JAF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/30/2009
Decision Date	12/24/2009
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