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

    AUTOPULSE RESUSCITATION SYSTEM MODEL100

    K Number: K063602 · Decision Dec 21, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    44
    Applicant Total
    5
    Review Days
    17

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    Basic Information

    Device Name
    AUTOPULSE RESUSCITATION SYSTEM MODEL100
    K Number
    K063602
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zoll Circulation
    Date Received
    December 4, 2006
    Decision Date
    December 21, 2006
    Product Code
    DRM
    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
    DRM Compressor, Cardiac, External

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    Other Clearances by Zoll Circulation

    K Number Device Name
    K141139 SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER
    K112998 AUTOPULSE RESUSCITATION SYSTEM MODEL 1000
    K101987 COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593
    K072527 AUTOPULSE RESUSCITATION SYSTEM, MODEL 100