LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K023010
    Device Name
    SNIFF POSITION PILLOWS/POPITZ PILLOWS
    Manufacturer
    AEOLUS INTERNATIONAL CORPORATION
    Date Cleared
    2002-10-01

    (22 days)

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

    AEOLUS INTERNATIONAL CORPORATION

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

    The Sniff Position Pillows are indicated for the following uses:

    • 1.) May improve the quality of sleep
    • 2.) May improve the symptoms of mild obstructive sleep apnea
    • 3.) May improve snoring
    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding the classification of "Sniff Position Pillows/Popitz Pillows." It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested information. The letter primarily addresses the regulatory classification of the device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1