BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    INFINITY MCABLE - MAINSTREAM CO2

    K Number: K100941 · Decision Apr 23, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    10
    Review Days
    18

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    INFINITY MCABLE - MAINSTREAM CO2
    K Number
    K100941
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Draeger Medical AG & Co. KG
    Date Received
    April 5, 2010
    Decision Date
    April 23, 2010
    Product Code
    CCK
    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
    CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (CCK), ordered by most recent decision date.

    Capnostream™35 Portable Respiratory Monitor (PM35MN)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Medical Gas Analyzer (AG200)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AIM (N/A)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by Draeger Medical AG & Co. KG

    K Number Device Name
    K102618 VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED
    K092029 VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310
    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