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

    ESOPHAGEAL STETHOSCOPE

    K Number: K823703 · Decision Jan 7, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    12
    Applicant Total
    2
    Review Days
    29

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    Basic Information

    Device Name
    ESOPHAGEAL STETHOSCOPE
    K Number
    K823703
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.1910
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Rsp, Inc.
    Date Received
    December 9, 1982
    Decision Date
    January 7, 1983
    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 Rsp, Inc.

    K Number Device Name
    K823702 EPIDURAL CATHETER