FDA 510(k) Application Details - K061935

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K061935
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	SENSACARE LTD. 2F, NO. 13, LANE 28, SEC. 1 HUANSHAN RD. NEI HU, TAIPEI 114 TW Other 510(k) Applications for this Company
Contact	STEVEN CHANG 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	07/10/2006
Decision Date	11/08/2006
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