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510(k) K113657

INTELLIVUE PATIENT MONITOR by Philips Medizin Systeme Boblingen GmbH — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2012
Date Received
December 12, 2011
Clearance Type
Traditional
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

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  • K032858 — THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE (October 10, 2003)
  • K031481 — THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RELEASE A.20 (May 29, 2003)

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