FDA 510(k) Application Details - K103652

Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

  More FDA Info for this Device
510(K) Number K103652
Device Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant PHILIPS MEDICAL SYSTESMS
300 MINUTEMAN ROAD
ANDOVER, MA 01810-1099 US
Other 510(k) Applications for this Company
Contact LAWRENCE MILANA
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 12/14/2010
Decision Date 01/13/2011
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact