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

    ZOLL E SERIES WITH SEE-THRU CPR

    K Number: K070455 · Decision Apr 26, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    227
    Applicant Total
    21
    Review Days
    69

    Basic Information

    Device Name
    ZOLL E SERIES WITH SEE-THRU CPR
    K Number
    K070455
    Device Class
    FDA class 3
    Clearance Type
    Special
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
    Date Received
    February 16, 2007
    Decision Date
    April 26, 2007
    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

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    K111296 ZOLL RESCUENETLINK
    K111594 ZOLL E SERIES
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