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510(k) Data Aggregation

    K Number
    K982098
    Device Name
    TUTODROP 1 AND TUTODROP 2
    Manufacturer
    MYCO MEDICAL SUPPLIES, INC.
    Date Cleared
    1999-03-01

    (259 days)

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

    TUTODROP 1 AND TUTODROP 2

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

    Used to control flow rate of IV Solution or medication to patient.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for medical devices named "TUTODROP 1" and "TUTODROP 2." This document primarily indicates that the devices have been found substantially equivalent to previously marketed devices.

    It does not contain the type of detailed study information, acceptance criteria, or performance data that would allow me to answer your specific questions regarding device acceptance criteria and a study proving device performance. The purpose of this letter is regulatory clearance, not a technical report of a study.

    Therefore, I cannot provide the requested information from the given input.

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