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

    END TIDAL CO2 NASAL CANNULA

    K Number: K120518 · Decision May 4, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    34
    Review Days
    73

    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
    END TIDAL CO2 NASAL CANNULA
    K Number
    K120518
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Care Fusion
    Date Received
    February 21, 2012
    Decision Date
    May 4, 2012
    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 Care Fusion

    K Number Device Name
    K233021 BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device
    K231888 BD Texium™ Needle-Free Syringe
    K221327 BD Alaris™ Pump Infusion Sets
    K221319 BD Alaris™ Pump Epidural Infusion Set
    K223101 BD Secondary Infusion Set
    K223088 BD SmartSite™ Needle-Free Connector
    K223076 BD Texium™ Closed Male Luer
    K201155 PleurX Peritoneal Catheter System
    K170405 BD Curve Ascites Shunt
    K171531 Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle
    Search all 34 clearances from Care Fusion →