FDA 510(k) Application Details - K180940

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K180940
Device Name	Computer, Diagnostic, Programmable
Applicant	Philips Medical Systems Nederland B.V. Veenpluis 4, -6 PC Best 5684 NL Other 510(k) Applications for this Company
Contact	Gina Crossetta 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	04/10/2018
Decision Date	10/24/2018
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