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

    ESOPHAGEAL STETHOSCOPE

    K Number: K844444 · Decision Jan 10, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    12
    Applicant Total
    6
    Review Days
    55

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    Basic Information

    Device Name
    ESOPHAGEAL STETHOSCOPE
    K Number
    K844444
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.1910
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Medical Parameters, Inc.
    Date Received
    November 16, 1984
    Decision Date
    January 10, 1985
    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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