FDA 510(k) Application Details - K013427

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K013427
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	PHILIPS MEDICAL SYSTEMS, INC. 3000 MINUTEMAN RD. ANDOVER, MA 01810-1099 US Other 510(k) Applications for this Company
Contact	DAVE OSBORN 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	10/16/2001
Decision Date	11/29/2001
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