FDA 510(k) Application Details - K161465

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K161465
Device Name	Computer, Diagnostic, Programmable
Applicant	MORTARA INSTRUMENT, INC. 7865 NORTH 86TH STREET Milwaukee, WI 53224 US Other 510(k) Applications for this Company
Contact	Margaret Mucha Other 510(k) Applications for this Contact
Regulation Number	870.1425   More FDA Info for this Regulation Number
Classification Product Code	DQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/27/2016
Decision Date	09/03/2016
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