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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    AdheResp Smart Breath-actuated Mesh Nebulizer

    K Number: K250583 · Decision Jun 20, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    2
    Review Days
    113

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    Basic Information

    Device Name
    AdheResp Smart Breath-actuated Mesh Nebulizer
    K Number
    K250583
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hcmed Innovations Co., Ltd.
    Date Received
    February 27, 2025
    Decision Date
    June 20, 2025
    Product Code
    CAF
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CAF Nebulizer (Direct Patient Interface)

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    Other Clearances by Hcmed Innovations Co., Ltd.

    K Number Device Name
    K202171 Pulmogine Vibrating Mesh Nebulizer