BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS

    K Number: K003548 · Decision Sep 4, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    227
    Applicant Total
    5
    Review Days
    291

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    Basic Information

    Device Name
    PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS
    K Number
    K003548
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Padpro, LLC
    Date Received
    November 17, 2000
    Decision Date
    September 4, 2001
    Product Code
    MKJ
    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
    MKJ Automated External Defibrillators (Non-Wearable)

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    Other Clearances by Padpro, LLC

    K Number Device Name
    K020743 PADPRO, MODEL 2502
    K020203 PADPRO MODEL #2516
    K020288 PADPRO, MODEL 2603
    K014209 PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS