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510(k) Data Aggregation

    K Number
    K200977
    Device Name
    Modular Toga
    Manufacturer
    Operating Room Innovations, Inc.
    Date Cleared
    2020-08-05

    (114 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Operating Room Innovation's Modular Toga are components of a personal protection system and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material.

    Device Description

    Modular Toga

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for a medical device called "Modular Toga". This document does not describe the acceptance criteria, the study that proves the device meets the acceptance criteria, or any of the other information you requested about a study (sample size, experts, adjudication, etc.).

    The letter is a regulatory document stating that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. It discusses regulatory requirements and refers to the "Indications for Use" statement, but it does not contain scientific study details about the device's performance.

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