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

    BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES

    K Number: K082982 · Decision Jul 20, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    5
    Review Days
    287

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    Basic Information

    Device Name
    BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES
    K Number
    K082982
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Breathe Technologies, Inc.
    Date Received
    October 6, 2008
    Decision Date
    July 20, 2009
    Product Code
    ONZ
    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
    ONZ Mechanical Ventilator

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    Other Clearances by Breathe Technologies, Inc.

    K Number Device Name
    K130037 BREATHE CPAP SYSTEM
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    K102525 BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)
    K100528 BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S