FDA 510(k) Application Details - K121638

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K121638
Device Name	Computer, Diagnostic, Programmable
Applicant	PHILIPS HEALTHCARE 1525 RANCHO CONEJO BLVD SUITE 100 THOUSAND OAKS, CA 91320 US Other 510(k) Applications for this Company
Contact	GRETAL LUMLEY 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	06/04/2012
Decision Date	07/18/2012
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