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510(k) Data Aggregation

    K Number
    K982241
    Device Name
    BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX
    Manufacturer
    DUXBURY SCIENTIFIC INC.
    Date Cleared
    1998-11-30

    (158 days)

    Product Code
    CAC
    Regulation Number
    868.5830
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX

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

    The Betatrans Intraoperative Autotransfusion System is designed for the collection and reinfusion of intraoperative drainage blood collected intraoperatively. The system is intended to reduce or eliminate the need for transfusion of homologous blood, which can carry a variety of infectious agent including Hepatitis or HIV.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the Betatrans Intraoperative Autotransfusion System. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

    Therefore, I cannot provide the requested information based on the given text. The letter only confirms that the device has been found substantially equivalent to a predicate device and can be marketed.

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