LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K040909
    Device Name
    SONO TT ULTRASONIC FLOWCOMPUTER
    Manufacturer
    EM-TEC GMBH
    Date Cleared
    2004-04-20

    (12 days)

    Product Code
    DPW
    Regulation Number
    870.2100
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Sono TT Ultrasonic Flowcomputer in combination with an ultrasonic clamp-on Transducer is indicated for the contact less volumetric measurement of liquid flowing through tubing systems. The measurement principle is the ultrasound transit-time method. The medical use of the device is appropriate in the following extracorporeal procedures: - Cardio-pulmonary bypass, membrane-oxygenation, hemodialysis, hemofiltration, plasmapheresis - Perfusion, infusion, transfusion - Several shunt-applications The Flowcomputer can be used in intensive care units and operating rooms. For the patient's safety the device is to be operated only by qualified medically-trained personnel.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for the "Sono TT Ultrasonic Flowcomputer," which confirms its substantial equivalence to previously marketed devices. It outlines the device's indications for use, contraindications, and regulatory information, but it does not detail specific acceptance criteria or performance study results.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1