FDA 510(k) Application Details - K172739

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K172739
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	higi SH LLC 800 Royal Oaks Dr. Suite 102 and 106 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	09/12/2017
Decision Date	10/10/2017
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