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

    LIFEPAK® 35 AC Power Adapter (41335-000001)

    K Number: K240162 · Decision Apr 19, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    88

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    Basic Information

    Device Name
    LIFEPAK® 35 AC Power Adapter (41335-000001)
    K Number
    K240162
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Physio-Control
    Date Received
    January 22, 2024
    Decision Date
    April 19, 2024
    Product Code
    MPD
    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
    MPD Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator

    Similar 510(k) Clearances

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

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    Other Clearances by Stryker Physio-Control

    K Number Device Name
    K240377 LIFEPAK® ECG Cables