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510(k) Data Aggregation

    K Number
    K102712
    Device Name
    MED GRAVITY SET, IMED PUMP SET
    Manufacturer
    IMED TECHNOLOGY, INC.
    Date Cleared
    2011-12-16

    (452 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The devices in the iMed Technology Enteral Feeding Set family are used to dispense liquid nutrients (feeding solutions) at a user controlled rate. These enteral feeding sets interface with the patient's feeding tube and may use gravity or an enteral feeding pump to dispense the feeding solution. The devices may include a bag to contain the feeding solution and/or a spike to connect to a pre-filled container. These devices are food containing. These devices are to be issued by prescription only.

    Device Description

    iMed Gravity Set, iMed Pump Set

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for "iMed Gravity Set, iMed Pump Set," which are enteral feeding sets. The FDA letter confirms substantial equivalence to legally marketed predicate devices, but it does not contain information about acceptance criteria, device performance testing, sample sizes, expert involvement, or any of the detailed study parameters requested in the prompt.

    Therefore, it's impossible to answer your request with the provided input. This document is a regulatory communication, not a study report.

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