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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
AN
Reference & Predicate Devices
N/A
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.

§ 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).