FDA 510(k) Application Details - K151127

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K151127
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	higi SH LLC 717 S Myrtle Ave Suite A Monrovia, CA 91016 US Other 510(k) Applications for this Company
Contact	Colin Hill 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	04/28/2015
Decision Date	12/08/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review