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

    LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060

    K Number: K961857 · Decision Jul 3, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    153
    Applicant Total
    8
    Review Days
    50

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    Basic Information

    Device Name
    LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060
    K Number
    K961857
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1875
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Graham-Field, Inc.
    Date Received
    May 14, 1996
    Decision Date
    July 3, 1996
    Product Code
    DQD
    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
    DQD Stethoscope, Electronic

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