Home / 510(k) Clearances / K101449

510(k) K101449

INTELLIVUE PATIENT MONITOR by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2010
Date Received
May 24, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN

  • K141015 — INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE P (May 19, 2014)
  • K132320 — INTELLIVUE CL RESPIRATION POD (March 26, 2014)
  • K131872 — INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550 (October 17, 2013)
  • K131829 — INTELLIVUE PATIENT MONITOR (August 16, 2013)
  • K130849 — INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450 (June 14, 2013)
  • K120366 — INTELLIVUE PATIENT MONITOR (July 18, 2012)
  • K113441 — PHYSIOLOGICAL MONITOR, PATIENT MONITOR (March 22, 2012)
  • K111905 — INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, (October 4, 2011)
  • K110474 — PHILIPS INTELLIVUE TCG10 (September 30, 2011)
  • K111083 — PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50 (August 17, 2011)

Other clearances for product code MHX

  • K253170 — uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors (April 16, 2026)
  • K252250 — Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasi (April 10, 2026)
  • K252726 — IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX10 (February 6, 2026)
  • K252589 — Corvair Monza (January 9, 2026)
  • K250854 — Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); (December 17, 2025)
  • K251702 — IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4 (November 10, 2025)
  • K251146 — IntelliVue Patient monitors MX400, MX450, MX500, MX550 (October 17, 2025)
  • K250453 — IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); (September 2, 2025)
  • K250179 — Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) (July 29, 2025)
  • K242562 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P (July 9, 2025)