LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K971844
    Device Name
    MCKINLEY OUTBOUND-2 SYSTEM
    Manufacturer
    MCKINLEY, INC.
    Date Cleared
    1998-01-23

    (249 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 :

    MCKINLEY OUTBOUND-2 SYSTEM

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

    The McKinley OUTBOUND-2 is indicated for patients requiring intravenous, interarterial, subcutaneous, or enteral administration of medication. It is convenient for use by ambulatory patients.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA letter (K971844) is entirely administrative and concerns the substantial equivalence determination for the "McKinley Outbound-2 System" device. It does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1