FDA 510(k) Application Details - K080854

Device Classification Name	Blood Pressure Cuff   More FDA Info for this Device
510(K) Number	K080854
Device Name	Blood Pressure Cuff
Applicant	SUNTECH MEDICAL, INC. 507 AIRPORT BOULEVARD SUITE 117 MORRISVILLE, NC 27560 US Other 510(k) Applications for this Company
Contact	DAVID GALLIK Other 510(k) Applications for this Contact
Regulation Number	870.1120   More FDA Info for this Regulation Number
Classification Product Code	DXQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/27/2008
Decision Date	10/20/2008
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