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510(k) K013624

MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V26 PATIENT MONITORS, BLOOD ANALYSIS PORTAL SYSTEM PLUG-I by Philips Medizin Systeme Boblingen GmbH — Product Code MHX

K013624 is an FDA 510(k) premarket notification submitted by Philips Medizin Systeme Boblingen GmbH for the device "MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V26 PATIENT MONITORS, BLOOD ANALYSIS PORTAL SYSTEM PLUG-I". The FDA issued a decision of Substantially Equivalent on December 3, 2001. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. Philips Medizin Systeme Boblingen GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2001
Date Received
November 5, 2001
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 Medizin Systeme Boblingen GmbH

  • K151736 — Philips IntelliVue GuardianSoftware (October 21, 2015)
  • 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)

Other clearances for product code MHX

  • K260656 — Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal (September 1, 2026)
  • K260343 — Carescape Canvas 1000; Carescape Canvas Smart Display (August 28, 2026)
  • K260579 — Infinity® Acute Care System (IACS) – VG8.1 (August 20, 2026)
  • K251508 — Telemetry Monitor (iT30, iT50) (August 6, 2026)
  • K253277 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P (July 24, 2026)
  • K254209 — Radius VSM and Accessories (June 4, 2026)
  • K252840 — M12 Telemetry System (May 29, 2026)
  • K260098 — ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A (May 20, 2026)
  • K250349 — Vista CMS (April 24, 2026)
  • K253170 — uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors (April 16, 2026)

FDA data resources