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    K Number
    K123729
    Device Name
    VERSARATE FLOW RATE CONTROLER
    Manufacturer
    EMED TECHNOLOGIES CORPORATION
    Date Cleared
    2012-12-21

    (16 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K890489
    Why did this record match?
    Device Name :

    VERSARATE FLOW RATE CONTROLER

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

    The VersaRate™ Flow Rate Controller is intended for use in the intravascular infusion of fluids to be delivered to the patient in a precise manner for no longer than 72 hours.

    Device Description

    The EMED VersaRate™ Flow Rate Controller is a disposable device allowing users to adjust the flow rate of fluids. The EMED VersaRate™ Flow Rate Controller can be connected to commercially available administration sets and fluid sources utilizing standard luer lock connectors.

    AI/ML Overview

    The EMED VersaRate™ Flow Rate Controller (K123729) is intended for use in the intravascular infusion of fluids delivered to the patient in a precise manner for no longer than 72 hours.
    The device's performance was evaluated against internal product specifications and requirements, as well as by comparison to a predicate device, the Baxter Extension Set w/Flow Regulator (K890489).

    Here's a breakdown of the acceptance criteria and study information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria / Performance CharacteristicVersaRate™ Flow Rate Controller Reported PerformancePredicate Device (Baxter Extension Set w/Flow Regulator) Performance
    Flow Rate Control Range5 – 230 mL/hr at 80 cm head height5 – 250 mL/hr
    Residual Volume of Set
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