FDA 510(k) Application Details - K131032

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

  More FDA Info for this Device
510(K) Number K131032
Device Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD
ANDOVER, MA 01810 US
Other 510(k) Applications for this Company
Contact MARY KRUITWAGEN
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 04/12/2013
Decision Date 08/12/2013
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



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