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

    IntelliVue Patient Monitor

    K Number: K150310 · Decision May 13, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    397
    Applicant Total
    48
    Review Days
    93

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    Basic Information

    Device Name
    IntelliVue Patient Monitor
    K Number
    K150310
    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 Boeblingen GmbH
    Date Received
    February 9, 2015
    Decision Date
    May 13, 2015
    Product Code
    DSI
    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
    DSI Detector And Alarm, Arrhythmia

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    Other Clearances by Philips Medizin Systeme Boeblingen GmbH

    K Number Device Name
    K252726 IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)
    K251146 IntelliVue Patient monitors MX400, MX450, MX500, MX550
    K233440 Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)
    K231671 IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)
    K230604 IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)
    K223574 IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)
    K210906 IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4
    K212208 Philips IntelliVue GuardianSoftware (Rev. E.0X)
    K192137 IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550
    K182979 IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3
    Search all 48 clearances from Philips Medizin Systeme Boeblingen GmbH →