Home / 510(k) Clearances / K151736

510(k) K151736

Philips IntelliVue GuardianSoftware by Philips Medizin Systeme Boblingen GmbH — Product Code DXJ

K151736 is an FDA 510(k) premarket notification submitted by Philips Medizin Systeme Boblingen GmbH for the device "Philips IntelliVue GuardianSoftware". The FDA issued a decision of Substantially Equivalent on October 21, 2015. The device falls under product code DXJ (Display, Cathode-Ray Tube, Medical), a Class II device regulated under 21 CFR 870.2450. Philips Medizin Systeme Boblingen GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2015
Date Received
June 26, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Display, Cathode-Ray Tube, Medical
Device Class
Class II
Regulation Number
870.2450
Review Panel
CV
Submission Type

Other clearances by Philips Medizin Systeme Boblingen GmbH

  • K140535 — PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50 (November 25, 2014)
  • K113657 — INTELLIVUE PATIENT MONITOR (March 22, 2012)
  • K102958 — PHILIPS AVALON FETAL MONITOR (March 18, 2011)
  • K102562 — INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, M (October 21, 2010)
  • K090360 — PHILIPS M3001A MULTI MEASUREMENT SERVER (May 4, 2009)
  • K083228 — PHILIPS INTELLIVUE MP5 PATIENT MONITOR (November 24, 2008)
  • K060541 — THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT MONITO (March 24, 2006)
  • K042845 — THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONI (November 12, 2004)
  • 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)

Other clearances for product code DXJ

  • K212003 — ESSENZ Patient Monitor (November 10, 2021)
  • K212208 — Philips IntelliVue GuardianSoftware (Rev. E.0X) (September 30, 2021)
  • K201162 — Essence 55SP Large Monitor System (August 27, 2020)
  • K173107 — Vios Central Station Monitor Software, Vios Central Server Software (July 26, 2018)
  • K180534 — Philips IntelliVue GuardianSoftware (July 16, 2018)
  • K173381 — Nexxis OR (February 22, 2018)
  • K172969 — Essence 55S Large Monitor System (January 26, 2018)
  • K170460 — Sorin Connect (June 8, 2017)
  • K170537 — Nexxis OR, Nexxis (April 21, 2017)
  • K161880 — NIVR58-T kit (March 14, 2017)

FDA data resources