FDA 510(k) Application Details - K121141

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K121141
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	TENSYS MEDICAL SYSTEMS, INC 5825 OBERLIN DRIVE SUITE 100 SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	Jamie Sulley 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	04/16/2012
Decision Date	05/15/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review