FDA 510(k) Application Details - K060820

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K060820
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	SUNTECH MEDICAL, INC. 507 AIRPORT BOULEVARD SUITE 117 MORRISVILLE, NC 27560 US Other 510(k) Applications for this Company
Contact	DAVID GALLICK 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	03/27/2006
Decision Date	06/07/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review