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510(k) Data Aggregation

    K Number
    K971818
    Device Name
    SNOREX
    Manufacturer
    Date Cleared
    1997-12-18

    (216 days)

    Product Code
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    SNOREX (NZ) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The use of the SNOREX device is indicated for anyone who snores, has a desire to alleviate or eliminate snoring, and has sufficient natural upper and lower teeth to hold the appliance in place while sleeping.
    Device Description
    The SNOREX is a custom formed mandibular splint designed to hold the lower jaw in a forward position while sleeping.
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