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

    Philips Holter Analysis System

    K Number: K241890 · Decision Mar 21, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    31
    Applicant Total
    10
    Review Days
    266

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    Basic Information

    Device Name
    Philips Holter Analysis System
    K Number
    K241890
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medizin Systeme Böblingen GmbH
    Date Received
    June 28, 2024
    Decision Date
    March 21, 2025
    Product Code
    MLO
    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
    MLO Electrocardiograph, Ambulatory, With Analysis Algorithm

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    Other Clearances by Philips Medizin Systeme Böblingen GmbH

    K Number Device Name
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    K253654 IntelliVue Measurement Rack 6000 (867317)
    K251702 IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 )
    K250453 IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)
    K242962 Telemetry Monitor 5500 Release 4.0 (867232)
    K243545 Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn
    K241556 Cardiac Workstation (5000); Cardiac Workstation (7000)
    K221348 IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)
    K211900 Patient Information Center iX