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510(k) Data Aggregation

    K Number
    K962074
    Device Name
    VM PLUS PEAK FLOWMETER
    Manufacturer
    CLEMENT CLARKE INTL., LTD.
    Date Cleared
    1997-01-02

    (219 days)

    Product Code
    BZH
    Regulation Number
    868.1860
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K962074
    Why did this record match?
    Device Name :

    VM PLUS PEAK FLOWMETER

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

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a Pre-Market Notification Certification and Summary for medical devices (VMX MINI-LOG FLOWMETER, VENTILOMETER VM1 and VM PLUS). It does not contain any information about acceptance criteria or a study proving device performance in the way requested for AI/machine learning model evaluation.

    This document focuses on:

    • Certification of awareness regarding safety and effectiveness problems for the listed devices.
    • Assertions about the absence of reported safety problems for the intended use.
    • Confirmation of compliance with a specific safety standard (International BS EN 1SO 60601-1).
    • Instruction on general medical hygiene and sterilization of the mouthpiece.
    • Identification of low battery power as an effectiveness issue, with a visual indicator provided.

    Therefore, I cannot extract the requested information (Table of acceptance criteria, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, ground truth types, training set size, or training ground truth establishment) from this document.

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