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

    SleepWeaver Advance Pediatric Nasal CPAP Mask

    K Number: K151683 · Decision Apr 5, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    459
    Applicant Total
    5
    Review Days
    288

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    Basic Information

    Device Name
    SleepWeaver Advance Pediatric Nasal CPAP Mask
    K Number
    K151683
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Circadiance, LLC
    Date Received
    June 22, 2015
    Decision Date
    April 5, 2016
    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 Circadiance, LLC

    K Number Device Name
    K162905 SleepWeaver 3D Nasal Mask
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    K120757 SLEEPWEAVER ELAN NASAL CPAP MASK
    K092362 SLEEPWEAVER NASAL CPAP MASK