BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Nebulizer

    K Number: K212395 · Decision Mar 25, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    4
    Review Days
    235

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    Basic Information

    Device Name
    Nebulizer
    K Number
    K212395
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Homed Medical Device Co., Ltd.
    Date Received
    August 2, 2021
    Decision Date
    March 25, 2022
    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 Shenzhen Homed Medical Device Co., Ltd.

    K Number Device Name
    K252616 Portable oxygen concentrator (JLO-190P)
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    K161586 The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)