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

    MODIFIED HEARTSTART 2000 DEFIBRILLATION ELECTRODE

    K Number: K900169 · Decision Jan 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    165
    Applicant Total
    5
    Review Days
    14

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    Basic Information

    Device Name
    MODIFIED HEARTSTART 2000 DEFIBRILLATION ELECTRODE
    K Number
    K900169
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Laerdal Mfg. Corp.
    Date Received
    January 12, 1990
    Decision Date
    January 26, 1990
    Product Code
    LDD
    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
    LDD Dc-Defibrillator, Low-Energy, (Including Paddles)

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    Other Clearances by Laerdal Mfg. Corp.

    K Number Device Name
    K902429 MODIFIED HEARTSTART DEFIBRILLATION ELECTRODE
    K885186 HEARTSTART 2000 DEFIBRILLATION ELECTRODE
    K883341 HEARTSTART 1000
    K883344 HEARTSTART 1000S