INTELLIVUE PATIENT MONITOR - MP30

• • Terminated Z-0545-2021 FDA Class II ·initiated 18 Nov 2020

  Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient.

• • Terminated Z-2626-2010 FDA Unclassified (pre-2012) ·initiated 31 Aug 2010

  Speakers on the Philips IntelliVue X2 and MP2 patient monitors may fail, causing absence of an audible alarm and delaying patient treatment.

510(k) Number

K083517 ↗

FDA Product Code

DSI

Models / Variants

MP2

MP5

MP20

MP30

MP40

MP50

MO60

MP7-

MP80

MP90

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Intellivue Patient Monitor

  Class II

  FDA 510(k) K110622 Active Cleared 31 Mar 2011

• Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50

  Class II

  FDA 510(k) K111083 Active Cleared 17 Aug 2011

• Intellivue Cl SP02 Pod Model 865215, Intellivue Cl Nbp Pod Model 865216, Intellivue Patient Monitors MP5, MP2, X2 Model

  Class II

  FDA 510(k) K101600 Active Cleared 31 Aug 2010

• Intellivue Guardian Software Model 866009, Intellivue Cl SP02 Pod Model 865215, Intellivue Cl Nbp Pod Model 865216

  Class II

  FDA 510(k) K111905 Active Cleared 4 Oct 2011

• Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 and MP90

  Class II

  FDA 510(k) K100939 Active Cleared 30 Apr 2010

• Intellivue Patient Monitor, Intellivue Xds, Models MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90

  Class II

  FDA 510(k) K082633 Active Cleared 3 Oct 2008

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