FDA 510(k) Application Details - K103693

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K103693
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
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	870.1130   More FDA Info for this Regulation Number
Classification Product Code	DXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/17/2010
Decision Date	02/15/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review