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510(k) K250453

IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500) by Philips Medizin Systeme Böblingen GmbH — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2025
Date Received
February 18, 2025
Clearance Type
Traditional
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 Böblingen GmbH

  • K251702 — IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4 (November 10, 2025)
  • K242962 — Telemetry Monitor 5500 Release 4.0 (867232) (May 5, 2025)
  • K241890 — Philips Holter Analysis System (March 21, 2025)
  • K243545 — Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 98980 (January 17, 2025)
  • K241556 — Cardiac Workstation (5000); Cardiac Workstation (7000) (December 17, 2024)
  • K221348 — IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (8664 (February 3, 2023)
  • K211900 — Patient Information Center iX (March 4, 2022)

Other clearances for product code MHX

  • 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)
  • 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)
  • K250757 — Radius VSM and Accessories (May 29, 2025)
  • K242962 — Telemetry Monitor 5500 Release 4.0 (867232) (May 5, 2025)
  • K240312 — Infinity CentralStation Wide (August 1, 2024)