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510(k) Data Aggregation

    K Number
    K202457
    Device Name
    M1 Surgical Face Mask
    Manufacturer
    CHISON Medical Technologies Co., Ltd.
    Date Cleared
    2021-04-29

    (245 days)

    Product Code
    FXX
    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

    When properly worn, the surgical face mask is intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate material. This device is non sterile and for single use only.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for a Surgical Face Mask. It is not a document describing an AI/ML medical device, nor does it contain information about acceptance criteria, study designs, sample sizes, expert ground truth establishment, or any of the other technical details typically associated with the evaluation of AI/ML devices.

    Therefore, I cannot extract the requested information from the provided text. The document pertains to a Class II medical device (M1 Surgical Face Mask) and focuses on its substantial equivalence to predicate devices, regulatory compliance, and indications for use, without any mention of AI/ML components or their performance evaluation.

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