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510(k) Data Aggregation

    K Number
    K014102
    Device Name
    PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251
    Manufacturer
    ATOS MEDICAL AB
    Date Cleared
    2002-02-21

    (70 days)

    Product Code
    JOH
    Regulation Number
    868.5800
    Type
    Special
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251

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

    The Provox HME system is a heat and moisture exchanger (HME) that heats and humidifies inhaled air by reclaiming heat and moisture from exhaled air in the device. For use by laryngectomees. The HME may also facilitate voicing.

    Device Description

    The Provox HME system is a heat and moisture exchanger (HME)

    AI/ML Overview

    This FDA document is a 510(k) clearance letter for the Provox HME System, not a study report or clinical trial. Therefore, it does not contain the information requested regarding acceptance criteria and a study proving device performance.

    The letter simply states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It lists the indications for use but does not provide any performance metrics, study design, or results.

    To answer your questions, one would need to access the actual 510(k) submission (K014102) itself, or any associated clinical study reports that were part of that submission, which are not provided in the text.

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