FDA 510(k) Application Details - K173895

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K173895
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	I.E.M. Industrielle Entwicklung and Medizintechnik Vertriebsgesellschaft mbH Cockerillstrabe 69 Stolberg 52222 DE Other 510(k) Applications for this Company
Contact	Hella Witt 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	12/21/2017
Decision Date	05/16/2019
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