FDA 510(k) Application Details - K151415

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K151415
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	IDT TECHNOLOGY LIMITED BLOCK C, 9/F., KAISER ESTATE, PHASE 1, 41 MAN YUE STREET., HUNG HOM, KOWLOON HONG KONG CN Other 510(k) Applications for this Company
Contact	LILY LI 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	05/27/2015
Decision Date	10/21/2015
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