VM PLUS PEAK FLOWMETER

• 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: AN
• Reference & Predicate Devices: K962074

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.

Regulation Number and Section

§ 868.1860 Peak-flow meter for spirometry.

(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).