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510(k) Data Aggregation

    K Number
    K982995
    Device Name
    ACCUTRAX, MODEL EPF840
    Manufacturer
    KORR MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1998-12-04

    (99 days)

    Product Code
    BZH
    Regulation Number
    868.1860
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K943678
    Why did this record match?
    Device Name :

    ACCUTRAX, MODEL EPF840

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

    This AccuTrax EPF840device is intended for monitoring PEF and FEV; for patient home and work use. The EPF840 is designed for pediatric to adult patients. The simple device interface provides ease of use for pediatric patients. When the EPF840 is used to watch lung conditions such as asthma, the user should be under the care of a licensed health care professional. A licensed health care professional's advise is required to understand the meaning and importance of the measures reported by the AccuTrax 840, and how to decide on an appropriate treatment plan. This treatment plan will tell you what action to take when there are changes in your PEF/FEV; numbers.

    Device Description

    The EPF840 is an electronic PEF/FEV; monitor. It can store PEF/FEV; test results, symptom scoring, and inhaler usage with a time and date stamp. The physician may retrieve data for analysis and trending using a personal computer. The physician may customize color zone indicators to the patient's needs.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the ACCUTRAX EPF840 Electronic Peak Flow Meter, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document primarily compares the ACCUTRAX EPF840 to a predicate device (Vitalograph 2110) against ATS (American Thoracic Society) standards. The acceptance criteria are implicitly the ATS standards for monitoring devices.

    ParameterAcceptance Criteria (ATS Standard for Monitoring Devices)ACCUTRAX Model EPF840 PerformancePredicate Device (2110) Performance
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