BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇳 China

    Ear Pressure Relief Device(Model:ER813B)

    K Number: K230502 · Decision Jun 9, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    105

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    Basic Information

    Device Name
    Ear Pressure Relief Device(Model:ER813B)
    K Number
    K230502
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ningbo Albert Novosino Co., Ltd.
    Date Received
    February 24, 2023
    Decision Date
    June 9, 2023
    Product Code
    MJV
    Advisory Committee
    Unknown
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MJV Device, Inflation, Middle Ear

    Similar 510(k) Clearances

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    Other Clearances by Ningbo Albert Novosino Co., Ltd.

    K Number Device Name
    K173044 Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff