BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT

    K Number: K993268 · Decision Apr 19, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    2
    Review Days
    202

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    Basic Information

    Device Name
    MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT
    K Number
    K993268
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mallinckrodt Dar S.R.L.
    Date Received
    September 30, 1999
    Decision Date
    April 19, 2000
    Product Code
    BTT
    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
    BTT Humidifier, Respiratory Gas, (Direct Patient Interface)

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    Other Clearances by Mallinckrodt Dar S.R.L.

    K Number Device Name
    K031997 MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM