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

    VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED

    K Number: K102618 · Decision Dec 10, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    10
    Review Days
    88

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    Basic Information

    Device Name
    VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED
    K Number
    K102618
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Draeger Medical AG & Co. KG
    Date Received
    September 13, 2010
    Decision Date
    December 10, 2010
    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 Draeger Medical AG & Co. KG

    K Number Device Name
    K092029 VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310
    K100941 INFINITY MCABLE - MAINSTREAM CO2
    K092999 NBP CUFF
    K083050 EVITE XL
    K081447 FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO
    K081743 CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS
    K072884 FABIUS MRI
    K072885 CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110
    K072002 FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55