BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LIFEPAK® ECG Cables

    K Number: K240377 · Decision May 7, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    104
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    LIFEPAK® ECG Cables
    K Number
    K240377
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Physio-Control
    Date Received
    February 7, 2024
    Decision Date
    May 7, 2024
    Product Code
    DSA
    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
    DSA Cable, Transducer And Electrode, Patient, (Including Connector)

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    Other Clearances by Stryker Physio-Control

    K Number Device Name
    K240162 LIFEPAK® 35 AC Power Adapter (41335-000001)