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510(k) Data Aggregation

    K Number
    K152561
    Device Name
    Communicator Surgical Facemask with Clear Window
    Manufacturer
    Prestige Ameritech, Ltd
    Date Cleared
    2016-06-03

    (268 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Communicator Surgical Facemask with Clear Window

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

    The Communicator Surgical Facemask with Clear Window, FM86000, is single use disposable intended to be worn in the operating room as well as dental, isolation, and other medical procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device: the "Communicator Surgical Facemask with Clear Window". It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The document is an FDA letter to the applicant, Prestige Ameritech, Ltd., stating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as classification, general controls, and compliance with federal statutes.

    Therefore, I cannot extract the requested information.

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