FDA 510(k) Application Details - K012487

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K012487
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	ATCOR MEDICAL PTY. LTD 1400 16TH STREET, NW SUITE 400 WASHINGTON, DC 20036 US Other 510(k) Applications for this Company
Contact	KIRSTEN PAULSON 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	08/02/2001
Decision Date	02/21/2002
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