FDA 510(k) Application Details - K061052

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K061052
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. HEWLETT-PACKARD-STR. 2 BOEBLINGEN D-71034 DE Other 510(k) Applications for this Company
Contact	HAUKE SCHIK Other 510(k) Applications for this Contact
Regulation Number	870.1025   More FDA Info for this Regulation Number
Classification Product Code	MHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/2006
Decision Date	05/26/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review