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

    BREATHE CPAP SYSTEM

    K Number: K130037 · Decision May 17, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    459
    Applicant Total
    5
    Review Days
    130

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    Basic Information

    Device Name
    BREATHE CPAP SYSTEM
    K Number
    K130037
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Breathe Technologies, Inc.
    Date Received
    January 7, 2013
    Decision Date
    May 17, 2013
    Product Code
    BZD
    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
    BZD Ventilator, Non-Continuous (Respirator)

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    Other Clearances by Breathe Technologies, Inc.

    K Number Device Name
    K103345 BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)
    K102525 BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)
    K100528 BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S
    K082982 BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES