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

    SOFTECH Plus ETCO2 Cannula

    K Number: K143469 · Decision Feb 12, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    64
    Review Days
    69

    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
    SOFTECH Plus ETCO2 Cannula
    K Number
    K143469
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Teleflexmedical, Inc.
    Date Received
    December 5, 2014
    Decision Date
    February 12, 2015
    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 Teleflexmedical, Inc.

    K Number Device Name
    K232469 Rüsch Latex Gold Foley Catheter
    K212077 Teleflex Rusch SoftSimplastic Foley Catheters
    K192324 Sheridan Spiral-Flex Endotracheal Tubes
    K182847 Hudson RCI Voldyne Volumetric Exerciser
    K181979 Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter
    K183461 Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter
    K181852 Percuvance Percutaneous Surgical System
    K173280 Neonatal ConchaSmart Breathing Circuits
    K172775 MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle
    K161770 Rusch Silicone Foley Catheter
    Search all 64 clearances from Teleflexmedical, Inc. →