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

    BOYLE SYSTEM ANESTHESIA GAS MACHINE

    K Number: K833151 · Decision Nov 14, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    187
    Applicant Total
    9
    Review Days
    60

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    Basic Information

    Device Name
    BOYLE SYSTEM ANESTHESIA GAS MACHINE
    K Number
    K833151
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5160
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Fraser Harlake, Inc.
    Date Received
    September 15, 1983
    Decision Date
    November 14, 1983
    Product Code
    BSZ
    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
    BSZ Gas-Machine, Anesthesia

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