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

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K111905 ↗

FDA Product Code

DXJ

Models / Variants

866009

Intellivue Cl SP02 Pod Model 865215

Intellivue Cl Nbp Pod Model 865216

Device Class

Class II

Regulation

21 CFR Part 870.2450

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 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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