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

    LIFESOUND ESOPHAGEAL STETHOSCOPE

    K Number: K811928 · Decision Jul 28, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    45
    Applicant Total
    3
    Review Days
    22

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    Basic Information

    Device Name
    LIFESOUND ESOPHAGEAL STETHOSCOPE
    K Number
    K811928
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1920
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Biomedical Concepts, Inc.
    Date Received
    July 6, 1981
    Decision Date
    July 28, 1981
    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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    Other Clearances by Biomedical Concepts, Inc.

    K Number Device Name
    K864858 LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR
    K844804 LIFESOUND - ELECTRONIC STETHOSCOPE