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

    MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO

    K Number: K823743 · Decision Jan 18, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    45
    Applicant Total
    78
    Review Days
    36

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    Basic Information

    Device Name
    MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO
    K Number
    K823743
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1920
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Y
    Date Received
    December 13, 1982
    Decision Date
    January 18, 1983
    Product Code
    BZT
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BZT Stethoscope, Esophageal, With Electrical Conductors

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