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

    LIFESOUND ESOPHAGEAL STETHOSCOPE

    K Number: K062020 · Decision Sep 5, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    45
    Applicant Total
    2
    Review Days
    50

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    Basic Information

    Device Name
    LIFESOUND ESOPHAGEAL STETHOSCOPE
    K Number
    K062020
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1920
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Novamed, LLC
    Date Received
    July 17, 2006
    Decision Date
    September 5, 2006
    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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