BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    Aerogen®Solo Nebulizer System

    K Number: K232507 · Decision May 10, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    5
    Review Days
    266

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    Basic Information

    Device Name
    Aerogen®Solo Nebulizer System
    K Number
    K232507
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aerogen, Ltd.
    Date Received
    August 18, 2023
    Decision Date
    May 10, 2024
    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 Aerogen, Ltd.

    K Number Device Name
    K251615 Aerogen Pro-X1 Controller System
    K133360 AERONEB SOLO; AERONEB SOLO ADAPTER
    K120939 AERONEB PRO
    K103635 CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S