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

    Philips IntelliVue GuardianSoftware (Rev. E.0X)

    K Number: K212208 · Decision Sep 30, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    77
    Applicant Total
    48
    Review Days
    77

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    Basic Information

    Device Name
    Philips IntelliVue GuardianSoftware (Rev. E.0X)
    K Number
    K212208
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medizin Systeme Boeblingen GmbH
    Date Received
    July 15, 2021
    Decision Date
    September 30, 2021
    Product Code
    DXJ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    DXJ Display, Cathode-Ray Tube, Medical

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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
    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
    K190624 EarlyVue VS30
    Search all 48 clearances from Philips Medizin Systeme Boeblingen GmbH →