Intellivue Patient Monitor

• 2 recalls, same reason

  • Terminated Z-2201-2010 FDA Unclassified (pre-2012) ·initiated 28 Jun 2010
  • Terminated Z-2202-2010 FDA Unclassified (pre-2012) ·initiated 28 Jun 2010

  Additional Instruction for Use for Intellivue MP60/MP70 to prevent monitors from becoming loose and detaching from the mounting arm.

510(k) Number

K093268 ↗

FDA Product Code

MHX

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, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, and MP90

  Class II

  FDA 510(k) K083517 Active Cleared 16 Jan 2009

See all devices from Philips Medizinsysteme Boeblingen GmbH, Cardiac AN →