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

    NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474

    K Number: K010093 · Decision Jun 14, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    8
    Review Days
    154

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    Basic Information

    Device Name
    NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474
    K Number
    K010093
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Drager Medizintechnik GmbH
    Date Received
    January 11, 2001
    Decision Date
    June 14, 2001
    Product Code
    CBK
    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
    CBK Ventilator, Continuous, Facility Use

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    Other Clearances by Drager Medizintechnik GmbH

    K Number Device Name
    K023289 OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072
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    K012177 VENTVIEW, MODEL 8414095
    K003068 SAVINA
    K010724 SOLA 700,SOLA 500, SOLA 300
    K003067 CALEO
    K984611 DRAGER SOLA SERIES, MODELS 1000/700/500/300