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510(k) Data Aggregation

    K Number
    K972843
    Device Name
    PROTOS BLOOD TRANSFUSION SET
    Manufacturer
    GLOBE ENT., INC.
    Date Cleared
    1997-12-16

    (137 days)

    Product Code
    BRZ
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PROTOS BLOOD TRANSFUSION SET

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

    For the delivery of blood or blood related solutions by or on the order of a physician or other licensed practitioner.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about the acceptance criteria and study proving device performance as requested. The text consists of an FDA 510(k) clearance letter for the "Protos Blood Transfusion Set" and its indications for use. This document confirms the device's substantial equivalence to a predicate device but does not detail performance studies, acceptance criteria, or any of the specific points you've asked for regarding AI/algorithm performance.

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