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Truzone Peak Flow Meter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K963089

by Monaghan Medical Corp.

Identifiers

510(k) Number
K963089 FDA 510(k)
FDA Product Code
BZH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.1860 FDA 510(k)
Regulation Number
868.1860 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Truzone Peak Flow Meter is a spirometry device used to measure peak expiratory flow. It is designed to record objective readings to help monitor respiratory health and lung function.

This device is regulated under FDA 510k clearance. It is intended for use as a measuring instrument for individuals managing respiratory conditions.

Frequently asked questions

What is the primary purpose of the Truzone Peak Flow Meter?

This device is a spirometry instrument designed to measure peak expiratory flow. It provides objective readings that assist individuals in monitoring their lung function and managing respiratory conditions.

Is the Truzone Peak Flow Meter regulated for use?

Yes, the device is regulated under FDA 510k clearance. It was reviewed under the Anesthesiology advisory committee and determined to be substantially equivalent to existing devices.

What is the regulatory classification of this device?

The Truzone Peak Flow Meter is classified as a Class 2 medical device under regulation number 868.1860, which pertains to peak flow meters used for spirometry.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TRUZONE® Peak Flow Meter » Monaghan Medical, MONAGHAN TRUZONE PFM INSTRUCTIONS MANUAL Pdf Download, TRUZONE Peak Flow Meter by Monaghan | Vitality Medical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Monaghan Medical Corp.

Sources (1)

  • FDA 510(k) K963089 24 fields · synced Sep 22, 2026