FDA 510(k) Application Details - K122129

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K122129
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	ATCOR MEDICAL 11/1059-1063 VICTORIA ROAD WEST RYDE NSW 2114 AU Other 510(k) Applications for this Company
Contact	JOHN ABRAM 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	07/18/2012
Decision Date	11/16/2012
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