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510(k) Data Aggregation

    K Number
    K991275
    Device Name
    WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS
    Manufacturer
    MCKINLEY, INC.
    Date Cleared
    1999-07-01

    (78 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS

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

    The pump is indicated for intravenous, subcutaneous, arterial, enteral, and epidural infusion of antibiotics, analgesics, chemotherapeutic agents and other medications or fluids requiring precisely-controlled infusion rates.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) clearance letter for an infusion pump, which is a hardware device. The questions you're asking are typically relevant to AI/ML (Artificial Intelligence/Machine Learning) powered software as a medical device (SaMD) or AI/ML components of a medical device. This document does not contain information related to AI/ML algorithms, performance studies, or acceptance criteria in the context of AI.

    Therefore, I cannot answer the questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided document. The document pertains to the regulatory clearance of a physical medical device (infusion pump) based on substantial equivalence to a predicate device.

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