FDA 510(k) Application Details - K112959

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K112959
Device Name	Electrocardiograph
Applicant	PHILIPS HEALTHCARE 1525 RANCHO CONEJO BLVD SUITE 100 THOUSAND OAKS, CA 91320 US Other 510(k) Applications for this Company
Contact	GRETEL LUMLEY Other 510(k) Applications for this Contact
Regulation Number	870.2340   More FDA Info for this Regulation Number
Classification Product Code	DPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/04/2011
Decision Date	01/26/2012
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