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

    ZOLL X SERIES

    K Number: K112432 · Decision Mar 21, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    227
    Applicant Total
    21
    Review Days
    211

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    Basic Information

    Device Name
    ZOLL X SERIES
    K Number
    K112432
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zoll Medical Corporation, World Wide Headquarters
    Date Received
    August 23, 2011
    Decision Date
    March 21, 2012
    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 Zoll Medical Corporation, World Wide Headquarters

    K Number Device Name
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    K120406 ZOLL FULLY AUTOMATIC AED PLUS
    K120907 ZOLL R SERIES
    K112761 ZOLL PROPAQ MD
    K111296 ZOLL RESCUENETLINK
    K111594 ZOLL E SERIES
    K110361 ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE
    K110154 ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE
    K110168 ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE
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