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

    ELECTRONIC STETHOSCOPE

    K Number: K761308 · Decision Jan 6, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    165
    Review Days
    14

    Basic Information

    Device Name
    ELECTRONIC STETHOSCOPE
    K Number
    K761308
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    MEDLINE INDUSTRIES, INC.
    Date Received
    December 23, 1976
    Decision Date
    January 6, 1977
    Product Code
    DPD
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DPD Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Charcoal Sep.

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