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

• • Terminated Z-0105-2015 FDA Class II ·initiated 3 Oct 2014

  Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped

510(k) Number

K111083 ↗

FDA Product Code

HGM

Device Class

Class II

Regulation

21 CFR Part 884.2740

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Intellivue Patient Monitor

  Class II

  FDA 510(k) K110622 Active Cleared 31 Mar 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

• 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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