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

    MAGLIFE

    K Number: K950264 · Decision Sep 27, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    424
    Applicant Total
    6
    Review Days
    613

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    Basic Information

    Device Name
    MAGLIFE
    K Number
    K950264
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Odam
    Date Received
    January 23, 1995
    Decision Date
    September 27, 1996
    Product Code
    MHX
    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
    MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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    Other Clearances by Odam

    K Number Device Name
    K972535 MAGLIFE C
    K854175 DEFIGARD 2000
    K823934 CARIEL F12
    K823931 DEFIGARD M(OR DEFISCOPE M
    K823933 MINIDEF (OR DEFIPORT