MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Class II

FDA Device Classification

Classification Details

Product Code
MHX
Device Class
Class II
Regulation Number
870.1025
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252726philips medizin systeme boeblingenIntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX10February 6, 2026
K252589alivecorCorvair MonzaJanuary 9, 2026
K250854shenzhen comen medical instruments coMulti-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); December 17, 2025
K251702philips medizin systeme böblingenIntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4November 10, 2025
K251146philips medizin systeme boeblingenIntelliVue Patient monitors MX400, MX450, MX500, MX550October 17, 2025
K250453philips medizin systeme böblingenIntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); September 2, 2025
K250179edan instrumentsPatient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)July 29, 2025
K242562ge medical systems information technologiesMonitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PJuly 9, 2025
K250757masimo corporationRadius VSM and AccessoriesMay 29, 2025
K242962philips medizin systeme böblingenTelemetry Monitor 5500 Release 4.0 (867232)May 5, 2025
K240312draeger medical systemsInfinity CentralStation WideAugust 1, 2024
K240320edan instrumentsPatient Monitor (RespArray)June 28, 2024
K231010alivecorCorvairJune 7, 2024
K232962edan instrumentsPatient Monitor (iX10, iX12, iX15)April 19, 2024
K232694edan instrumentsCentral Monitoring System (MFM-CMS)February 5, 2024
K231671philips medizin systeme boeblingenIntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866December 19, 2023
K230604philips medizin systeme boeblingenIntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module XNovember 22, 2023
K231477draeger medical systemsInfinity CentralStation Wide, Infinity M300, Infinity M300+October 17, 2023
K223574philips medizin systeme boeblingenIntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866August 22, 2023
K221056schillerARGUS PB-3000July 6, 2023