BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT MONITORS

    K Number: K060541 · Decision Mar 24, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    424
    Applicant Total
    12
    Review Days
    23

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT MONITORS
    K Number
    K060541
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medizin Systeme Boblingen GmbH
    Date Received
    March 1, 2006
    Decision Date
    March 24, 2006
    Product Code
    MHX
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MHX), ordered by most recent decision date.

    Radius VSM and Accessories

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    M12 Telemetry System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Vista CMS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Philips Medizin Systeme Boblingen GmbH

    K Number Device Name
    K151736 Philips IntelliVue GuardianSoftware
    K140535 PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50
    K113657 INTELLIVUE PATIENT MONITOR
    K102958 PHILIPS AVALON FETAL MONITOR
    K102562 INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800
    K090360 PHILIPS M3001A MULTI MEASUREMENT SERVER
    K083228 PHILIPS INTELLIVUE MP5 PATIENT MONITOR
    K042845 THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS
    K032858 THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O.
    K031481 THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RELEASE A.20
    Search all 12 clearances from Philips Medizin Systeme Boblingen GmbH →