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510(k) Data Aggregation

    K Number
    K123095
    Device Name
    MEDLINE BLOOD PRESSURE TRANSDUCER
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    2013-05-08

    (218 days)

    Product Code
    DRS
    Regulation Number
    870.2850
    Type
    Abbreviated
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MEDLINE BLOOD PRESSURE TRANSDUCER

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

    Medine Blood Pressure Transducer is intended for direct measurement and monitoring of blood pressure. This disposable transducer is intended for single use only. Indications for use include: - . Direct arterial blood pressure monitoring - central and peripheral - Pulmonary artery monitoring (PA distal) . - Venous pressure monitoring (RA Proximal) ● - Left atrial monitoring when used with an air eliminator . - Cardiac catheterization .

    Device Description

    Medline Blood Pressure Transducer

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding the Medline Blood Pressure Transducer. It does not contain information about acceptance criteria or a study that proves the device meets those criteria. Such information would typically be found in the 510(k) summary or the full submission, which are not provided here.

    Therefore, I cannot answer the questions based on the provided text.

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