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

    INTROSCOPE

    K Number: K953793 · Decision Nov 29, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    45
    Applicant Total
    20
    Review Days
    107

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    Basic Information

    Device Name
    INTROSCOPE
    K Number
    K953793
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1920
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Polamedco, Inc.
    Date Received
    August 14, 1995
    Decision Date
    November 29, 1995
    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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