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510(k) Data Aggregation

    K Number
    K071244
    Device Name
    MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    2008-03-05

    (307 days)

    Product Code
    DXQ,DXO
    Regulation Number
    870.1120
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF

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

    The Medline Single Patient Use Blood Pressure Cuff is intended to be used in conjunction with non-invasive blood pressure monitoring systems for determination of a person's blood pressure. The device is non-sterile and disposable. It is available in neonatal, infant, and adult sizes.

    Device Description

    Medline Single Patient Use Blood Pressure Cuffs:
    Neonatal, single tube
    Neonatal, double tube
    Infant - Adult, Disposable double tube
    Infant - Adult, Disposable single tube

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for Medline Single Patient Use Blood Pressure Cuffs. This document primarily focuses on regulatory approval and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

    Therefore, I cannot answer your request based on the provided text. The document is a regulatory approval letter, not a scientific study report.

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