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

    PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)

    K Number: K102404 · Decision Dec 2, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    4
    Applicant Total
    5
    Review Days
    100

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    Basic Information

    Device Name
    PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)
    K Number
    K102404
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5570
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ventus Medical, Inc.
    Date Received
    August 24, 2010
    Decision Date
    December 2, 2010
    Product Code
    OHP
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OHP Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea

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    Other Clearances by Ventus Medical, Inc.

    K Number Device Name
    K120665 INVENT SNORING DEVICE
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