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510(k) Data Aggregation

    K Number
    K102971
    Device Name
    FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK
    Manufacturer
    MICROTEK MEDICAL, INC.
    Date Cleared
    2011-02-23

    (140 days)

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

    FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK

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

    The Freedomaire III Surgical Helmet System is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel in order to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA regarding the "Freedomaire III Surgical Helmet System." It primarily confirms that the device is substantially equivalent to legally marketed predicate devices and does not contain detailed information about specific acceptance criteria or an overarching study proving the device meets said criteria.

    Therefore, I cannot provide the requested information from this document. The document focuses on regulatory approval based on equivalence rather than performance study results against specific criteria.

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