FDA 510(k) Application Details - K201081

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K201081
Device Name	Computer, Diagnostic, Programmable
Applicant	Philips Medical System Nederland B.V. Veenpluis 4-6 Best 5684 PC NL Other 510(k) Applications for this Company
Contact	Gert De Vries 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	04/22/2020
Decision Date	12/17/2020
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