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

    THE BLOOM STETHOSCOPE

    K Number: K830796 · Decision Jul 19, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    180
    Registration Numbers
    180
    Same Product Code
    27
    Applicant Total
    1
    Review Days
    127

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    Basic Information

    Device Name
    THE BLOOM STETHOSCOPE
    K Number
    K830796
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.1875
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Stethophonics, Inc.
    Date Received
    March 14, 1983
    Decision Date
    July 19, 1983
    Product Code
    LDE
    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
    LDE Stethoscope, Manual

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