FDA 510(k) Application Details - K122443

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K122443
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	BIOSIGN TECHNOLOGIES, INC. 9001 WESLEYAN RD, SUITE 200 INDIANAPOLIS, IN 46268 US Other 510(k) Applications for this Company
Contact	ALLISON SCOTT, RAC 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	08/10/2012
Decision Date	11/20/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review