FDA 510(k) Application Details - K060315

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K060315
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	HEALTHSTATS INTERNATIONAL PTE. LTD. S65 W35739 PIPER ROAD EAGLE, WI 53119 US Other 510(k) Applications for this Company
Contact	STEPHEN GORSKI 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	02/08/2006
Decision Date	04/07/2006
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	N
Expedited Review