LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K013421
    Device Name
    LIFEGUARD NASAL CPAP MASK AND ACCESSORIES
    Manufacturer
    LIFEGUARD MEDICAL PRODUCTS, INC.
    Date Cleared
    2002-01-08

    (84 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Lifeguard Nasal CPAP mask is intended to be used to provide nasal CPAP, when used with devices that provided an exhalation port, devices that provide When about with devices that support the mask against the patient's face. The mask is intended for re-use by a single patient.

    Device Description

    Lifeguard Nasal CPAP Mask

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance results, or any study details that would allow me to populate the requested table and answer the subsequent questions. The document is an FDA 510(k) clearance letter for a "Lifeguard Nasal CPAP Mask," confirming its substantial equivalence to a predicate device. It defines the product and its intended use but does not include any performance data or study specifics.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1