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510(k) Data Aggregation

    K Number
    K062300
    Device Name
    OX-SOX, MODEL C, D, E,
    Manufacturer
    PATTIENT SAFETY INNOVATIONS, LLP
    Date Cleared
    2006-11-27

    (111 days)

    Product Code
    ECX
    Regulation Number
    868.2700
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PATTIENT SAFETY INNOVATIONS, LLP

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

    The Ox-Sox is designed to fit over and clearly identify "E" Oxygen cylinders, both in healthcare facilities and for home use. The device is for use with gas cylinders containing oxygen.

    Device Description

    The Ox-Sox is designed to fit over and clearly identify "E" Oxygen cylinders.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria, device performance, or any study details that would allow for the construction of such a table or the answering of the subsequent questions. The document is an FDA 510(k) clearance letter for the Ox-Sox device, indicating it is substantially equivalent to legally marketed predicate devices, and outlines its indications for use as a cover to identify "E" Oxygen cylinders. It does not include performance data or study results.

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