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510(k) Data Aggregation

    K Number
    K983448
    Device Name
    ML UNIVERSAL TUBING
    Manufacturer
    MED-LOGICS, INC.
    Date Cleared
    1998-12-18

    (79 days)

    Product Code
    MSR
    Regulation Number
    886.4150
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ML UNIVERSAL TUBING

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

    Irrigation and Aspiration of fluids during Ophthalmic phacoemulsification procedures.

    Device Description

    Med-Logics, Inc., Administration Set (UT 3004)
    Med-Logics, Inc., Drainage Bag (UT 3002)
    Med-Logics, Inc., Universal Tubing Set (UT 3000)

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding Med-Logics, Inc.'s Administration Set, Drainage Bag, and Universal Tubing. This document is a regulatory letter approving a medical device based on its substantial equivalence to pre-existing devices. It does not contain information about acceptance criteria or study results in the context of device performance, algorithm evaluation, or clinical trials which are typically found in design validation reports or clinical study summaries.

    Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on regulatory approval rather than technical performance data or study methodologies.

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