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510(k) Data Aggregation

    K Number
    K984085
    Device Name
    RITEFLO SPACER
    Manufacturer
    AEROMAX TECHNOLOGIES, INC.
    Date Cleared
    1999-08-05

    (262 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    AEROMAX TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Intelliflo Spacer is intended to be used in combination with Metered Dose Inhaler's (MDI) to assist in respiratory steroid drug delivery. The target population includes all patients using MDI's i.e., children, elderly, and adults.
    Device Description
    Not Found
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