FDA 510(k) Application Details - K153557

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K153557
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	I.E.M. GMBH COCKERILLSTR. 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	12/14/2015
Decision Date	07/19/2016
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