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510(k) Data Aggregation

    K Number
    K980738
    Device Name
    PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION
    Manufacturer
    BYRON MEDICAL
    Date Cleared
    1998-06-16

    (111 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K820937,K973133,K953574
    Why did this record match?
    Device Name :

    PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION

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

    General surgical fluid irrigation and infiltration.
    The Psi-Tec Syringe Infusion Pump and accessories indications for use are for General Fluid Irrigation/Infiltration.

    Device Description

    The principles of operation and technology incorporated in the Psi-Tec Svringe Infusion Pump and accessories are to provide controlled fluid delivery by utilizing a disposable, pneumatically driven syringe cartridge attached to tubing, that can propel and monitor fluid volumes delivered into a surgical site by the system.

    AI/ML Overview

    This document is a 510(k) summary for the Byron Medical Psi-Tec Syringe Infusion Pump. It does not contain information about acceptance criteria or a study proving the device meets said criteria.

    Therefore, I cannot provide the requested information. The document focuses on establishing substantial equivalence to previously cleared devices for the purpose of market clearance, rather than presenting performance study data against specific acceptance criteria.

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