BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MAGNO ALARM

    K Number: K960849 · Decision Mar 26, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    4
    Applicant Total
    3
    Review Days
    400

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    Basic Information

    Device Name
    MAGNO ALARM
    K Number
    K960849
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.3690
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiac Assist Devices, Inc.
    Date Received
    February 20, 1996
    Decision Date
    March 26, 1997
    Product Code
    DTG
    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
    DTG Magnet, Test, Pacemaker

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