TRUZONE PEAK FLOW METER

K955262 · Monaghan Medical Corp. · BZH · Mar 7, 1996 · Anesthesiology

Device Facts

• Record ID: K955262
• Device Name: TRUZONE PEAK FLOW METER
• Applicant: Monaghan Medical Corp.
• Product Code: BZH · Anesthesiology
• Decision Date: Mar 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1860
• Device Class: Class 2

Intended Use

The TruZone Peak Flow Meter is a simple mechanical device that responds to and indicates the Peak Expiratory Flow Rate (PEFR) generated by the user during a forced exhalation maneuver.

Device Story

Mechanical device; measures Peak Expiratory Flow Rate (PEFR). User places inlet in mouth; performs forced exhalation from full lungs. Internal piston extends spring via pressure spike; indicator moves to maximum displacement position. Indicator remains at peak value; user reads value in liters per minute from scale. Logarithmic piston displacement provides higher resolution at lower flow rates. Used by patients for self-monitoring or clinicians for assessment. Modification adds ColorZone tapes as accessory for physician use.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical peak flow meter; logarithmic piston displacement mechanism; spring-loaded; manual scale readout. No electronic components, software, or energy source.

Indications for Use

Indicated for patients requiring measurement of Peak Expiratory Flow Rate (PEFR) via forced exhalation maneuver.

Regulatory Classification

Identification

A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.

Predicate Devices

• TruZone Peak Flow Meter (K926307)

Submission Summary (Full Text)

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K955262

# SECTION 2 - SUMMARY AND CERTIFICATION

## 510(k) SUMMARY

Monaghan Medical Corporation
5 Latour Ave., Suite 1600
P.O. Box 2805
Plattsburgh, NY 12901-0299
Phone: [phone] Fax: [phone]
Contact: James A. Cochie
QA/RA Manager

**Date Prepared:** October 31, 1995

**Device Proprietary Name:** TruZone Peak Flow Meter
**Device Classification name:** Peak Flow Meter for Spirometry, 73 BZH

**Legally Marketed Device Identity:** TruZone Peak Flow Meter, 510(k) #926307

## Device Description:

The TruZone Peak Flow Meter is a simple mechanical device that responds to and indicates the Peak Expiratory Flow Rate (PEFR) generated by the user during a forced exhalation maneuver.

The inlet of the device is placed into the user's mouth after which the maximum rate at exhalation is attempted from nearly full lungs. As this forced exhalation commences an internal piston extends a spring as reaction to an internal pressure spike. An indicator is pushed by the moving piston and remains at the maximum displacement position of the piston after the maneuver is terminated. This position corresponds to the PEFR and is quantified in liters per minute by reading a scale next to the indicator. The piston displacement function is logarithmic thereby providing greater resolution of scale at lower PEFR readings.

The TruZone Peak Flow Meter is identical in form and function to the TruZone Peak Flow Meter as described in its 510(k) #926307 except for the addition of a separate package of ColorZone tapes as an accessory to the TruZone Peak Flow Meter. The essence of the modification to this 510(k) is adding the aforementioned accessory package for sale to physicians.