BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    INVENT SNORING DEVICE

    K Number: K120665 · Decision Jun 12, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    19
    Applicant Total
    5
    Review Days
    99

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    Basic Information

    Device Name
    INVENT SNORING DEVICE
    K Number
    K120665
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3900
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ventus Medical, Inc.
    Date Received
    March 5, 2012
    Decision Date
    June 12, 2012
    Product Code
    LWF
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LWF Dilator, Nasal

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    Other Clearances by Ventus Medical, Inc.

    K Number Device Name
    K102404 PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)
    K090398 PROVENT PROFESSIONAL SLEEP APNEA THERAPY
    K080983 PROVENT NASAL CANNULA
    K071560 PROVENT NASAL DILATOR, MODEL BR2