BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Flexicare Heated Wire Breathing Systems

    K Number: K150900 · Decision May 15, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    45
    Applicant Total
    7
    Review Days
    42

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    Basic Information

    Device Name
    Flexicare Heated Wire Breathing Systems
    K Number
    K150900
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5270
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Flexicare Medical, Ltd.
    Date Received
    April 3, 2015
    Decision Date
    May 15, 2015
    Product Code
    BZE
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

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    Other Clearances by Flexicare Medical, Ltd.

    K Number Device Name
    K140473 DUALGUARD
    K140113 O2 NASAL CANNULA WITH CO2 MONITORING
    K132619 CLASSIC INTERMITTENT CATHETER
    K092218 FLEXICARE BREATHING FILTERS
    K091591 FLEXICARE MEDICAL ENDOTRACHEAL TUBES
    K951652 VENTIMASK MK IV