FDA 510(k) Application Details - K173028

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K173028
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	HealthSTATS International Pte Ltd 3 Ang Mo Kio Street 62 #08-25/26, Link@Amk Singapore 536199 SG Other 510(k) Applications for this Company
Contact	Ngak Hwee Chua 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	09/28/2017
Decision Date	06/21/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review