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510(k) Data Aggregation

    K Number
    K040161
    Device Name
    SONA PILLOW
    Manufacturer
    SLEEP DEVICES, INC.
    Date Cleared
    2004-04-30

    (98 days)

    Product Code
    MYB
    Regulation Number
    872.5570
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SLEEP DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    1- MAY STOP OR DECREASE SNORING

    2- MAY BE USED TO TREAT MILD OBSTRUCTIVE SLEEP APNEA

    3- MAY IMPROVE THE QUALITY OF SLEEP

    Device Description

    Not Found

    AI/ML Overview

    This document is a marketing clearance letter from the FDA for the Sona Pillow, classifying it as an intraoral device for snoring and obstructive sleep apnea. It does not contain information about acceptance criteria or a study proving the device meets those criteria. Therefore, I cannot provide the requested information based on the input document.

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