510(k) K131829

INTELLIVUE PATIENT MONITOR by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN — Product Code MHX

K131829 is an FDA 510(k) premarket notification submitted by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN for the device "INTELLIVUE PATIENT MONITOR". The FDA issued a decision of Substantially Equivalent on August 16, 2013. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. Philips Medizinsysteme Boeblingen GmbH, Cardiac AN has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2013
Date Received
June 20, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type