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510(k) Data Aggregation

    K Number
    K982334
    Device Name
    AIRZONE PEAK FLOWMETER
    Manufacturer
    CLEMENT CLARKE INTL., LTD.
    Date Cleared
    1999-01-14

    (196 days)

    Product Code
    BZH
    Regulation Number
    868.1860
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AIRZONE PEAK FLOWMETER

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

    The AirZone Peak Flowmeter is intended to measure the peak expiratory flow rate for patients who have respiratory conditions such as Asthma, Emphysema or Reversible Airway Obstruction.

    Device Description

    AirZone Peak Flowmeter

    AI/ML Overview

    This document is a 510(k) premarket notification for the AirZone Peak Flowmeter, which is a device for measuring peak expiratory flow rate. It is a regulatory approval document and does not contain information about the acceptance criteria or a study proving the device meets said criteria in the format requested. The document confirms that the device is substantially equivalent to legally marketed predicate devices and can proceed to market, but it does not provide performance data or study details. Therefore, I cannot extract the requested information from this document.

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