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510(k) Data Aggregation

    K Number
    K990388
    Device Name
    TUTOPLUS IV ADMINISTRATION SET
    Manufacturer
    MYCO MEDICAL SUPPLIES, INC.
    Date Cleared
    1999-03-29

    (49 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TUTOPLUS IV ADMINISTRATION SET

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Device to be used to administer IV Solution or medication to patient.

    Device Description

    "TUTOPLUS" Sterile Disposable Intravascular Administration Set

    AI/ML Overview

    I'm sorry, but this document is not a study. It is a 510(k) premarket notification letter from the FDA to Myco Medical Supplies, Inc. regarding their "TUTOPLUS" IV Administration Set.

    Therefore, I cannot extract the requested information as it is not present in this document. This letter only indicates that the device has been found substantially equivalent to predicate devices and can be marketed. It does not contain any details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

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