FDA 510(k) Application Details - K160967

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K160967
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	FINAPRES MEDICAL SYSTEMS BV HOGEHILWEG 8 AMSTERDAM 1101 CC NL Other 510(k) Applications for this Company
Contact	IR. IRIS VAN UITERT 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	04/06/2016
Decision Date	04/18/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review