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510(k) Data Aggregation

    K Number
    K190962
    Device Name
    Bella-mu
    Manufacturer
    U-Needle B.V.
    Date Cleared
    2020-02-03

    (297 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    U-Needle B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bella-mu is indicated for intradermal injections of FDA approved drugs for patients 18 years of age and older. The Bella-mu is to be inserted in the dermis of the suprascapular, deltoid, waist, or thigh regions.
    Device Description
    Not Found
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