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510(k) Data Aggregation

    K Number
    K021480
    Device Name
    EXTENSION SET LIGHT-SAFE, MODEL BC565
    Manufacturer
    CODAN US CORP.
    Date Cleared
    2002-06-27

    (50 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 :

    EXTENSION SET LIGHT-SAFE, MODEL BC565

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

    The CODAN US Extension Set is indicated to facilitate the infusion of IV fluids from a plastic bag or solution container into the patient.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device called "Extension Set Light-Safe BC565." This document outlines the regulatory approval of the device and confirms its substantial equivalence to a legally marketed predicate device.

    However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment.

    The document is purely a regulatory clearance and does not detail the technical performance or validation studies of the device. Therefore, I cannot generate the requested table and information based on the provided text.

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