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510(k) Data Aggregation

    K Number
    K182906
    Device Name
    Portable Mesh Nebulizer
    Manufacturer
    FeelLife Health Inc.
    Date Cleared
    2020-09-27

    (711 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Portable Mesh Nebulizer

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

    The device is a Vibrating Mesh Nebulizer System that designed to aerosolize liquid medication for inhalation therapy by the patient. It is not intended for use with Pentamidine.

    Device Description

    Vibrating Mesh Nebulizer System

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria for a device, nor does it describe a study proving a device meets acceptance criteria.

    The document is an FDA 510(k) clearance letter for a "Portable Mesh Nebulizer" and primarily focuses on:

    • The FDA's review and determination of substantial equivalence.
    • Regulatory requirements for the device.
    • Instructions for use, patient population, and environment of use for the device.

    Therefore, I cannot fulfill your request based on the given input.

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