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

    MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR

    K Number: K874519 · Decision Jan 29, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    12
    Applicant Total
    17
    Review Days
    88

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    Basic Information

    Device Name
    MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR
    K Number
    K874519
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.1910
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Mon-A-Therm, Inc.
    Date Received
    November 2, 1987
    Decision Date
    January 29, 1988
    Product Code
    BZW
    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
    BZW Stethoscope, Esophageal

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    Other Clearances by Mon-A-Therm, Inc.

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