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

    DEBUSK TEMP. SYST. ESOPHAGEAL STETHOSCOPE

    K Number: K925789 · Decision Jul 13, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    45
    Applicant Total
    91
    Review Days
    239

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    Basic Information

    Device Name
    DEBUSK TEMP. SYST. ESOPHAGEAL STETHOSCOPE
    K Number
    K925789
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1920
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Deroyal Industries, Inc.
    Date Received
    November 16, 1992
    Decision Date
    July 13, 1993
    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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