FDA 510(k) Application Details - K070795

Device Classification Name	Computer, Blood-Pressure   More FDA Info for this Device
510(K) Number	K070795
Device Name	Computer, Blood-Pressure
Applicant	ATCOR MEDICAL PTY. LTD 1400 16TH STREET, NW SUITE 400 WASHINGTON, DC 20036 US Other 510(k) Applications for this Company
Contact	EVAN P PHELPS Other 510(k) Applications for this Contact
Regulation Number	870.1110   More FDA Info for this Regulation Number
Classification Product Code	DSK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/22/2007
Decision Date	08/31/2007
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