LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K251659

    Validate with FDA (Live)

    Device Name
    Mesh Nebulizer (H6)
    Manufacturer
    Qingdao Future Medical Technology Co.,Ltd.
    Date Cleared
    2025-11-14

    (168 days)

    Product Code
    CAF,BYG,BYP
    Regulation Number
    868.5630
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K171549
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Mesh Nebulizer designed to aerosolized liquid medications for inhalation by patient, the device may be used with pediatric (> 4 years of age) and adult patients in the home, hospital and sub-acute care settings.

    It is not intended for use with Pentamidine.

    Device Description

    The Mesh Nebulizer H6 is a portable handheld device that uses micromesh vibration technology to generate aerosols for inhalation by patients. The H6 consists of a main unit, a nebulizer cup and optional accessories, including inhalation masks (available in child and adult sizes), a mouthpiece and a power cord. The main unit housing is made of ABS material, the nebulizer cup is made of PC material, the inhalation mask is made of PP&TPE&silicone material, and the mouthpiece is made of PP&silicone material. It can be powered by an internal lithium battery or by an adapter that complies with the IEC 60601-1 standard.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1