Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K251847

    Validate with FDA (Live)

    Date Cleared
    2026-01-15

    (213 days)

    Product Code
    Regulation Number
    868.5905
    Age Range
    18 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    F&P Evora Full Face Mask, K212371

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

    The Sleepnet Arie Full Face Vented Mask is intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 4 cm H2O. The mask is to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single-patient multi-use in the home, hospital, or institutional environment.

    The Sleepnet Arie Nasal Vented Mask is intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 4 cm H2O. The mask is to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single-patient multi-use in the home, hospital, or institutional environment.

    Device Description

    The Sleepnet Arie Full Face Vented and Nasal Mask are designed based on the human facial shape, and the operating characteristics during application. The Sleepnet mask utilizes a Liquid Silicone Rubber (LSR) cushion design. The device is composed of medical-grade injection molded thermoplastics & clear liquid silicone rubber. The device is used as the interface between a CPAP/BiPAP machine and the end user. The masks are held in place with adjustable headgear that straps the mask to the face.

    The Arie Full Mask is accompanied by a vented frame/tubing assembly which includes the Arie Full Face Vented Mask Headgear connector, valve, swivel ball, tubing, swivel connector assembly (swivel connector and clear swivel), and the JustFit Full Face Headgear with clips.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1