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

    ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)

    K Number: K032439 · Decision Nov 5, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    227
    Applicant Total
    33
    Review Days
    90

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    Basic Information

    Device Name
    ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)
    K Number
    K032439
    Device Class
    FDA class 3
    Clearance Type
    Abbreviated
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Zoll Medical Corp
    Date Received
    August 7, 2003
    Decision Date
    November 5, 2003
    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 Corp

    K Number Device Name
    K133484 ZOLL X SERIES
    K112660 POCKETCPR
    K090989 ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES
    K042007 ZOLL E SERIES DEFIBRILLATOR
    K042302 ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE
    K042417 ZOLL M SERIES ETC02 LOFLO OPTION
    K033474 ZOLL AED PLUS
    K032691 ZOLL AUTOCLAVABLE INTERNAL HANDLES
    K032363 ZOLL M SERIES NIBP OPTION
    K011541 ZOLL PAD WITH CPR AID
    Search all 33 clearances from Zoll Medical Corp →