K963089 · Monaghan Medical Corp. · BZH · Nov 6, 1996 · Anesthesiology
Device Facts
Record ID
K963089
Device Name
TRUZONE PEAK FLOW METER
Applicant
Monaghan Medical Corp.
Product Code
BZH · Anesthesiology
Decision Date
Nov 6, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 868.1860
Device Class
Class 2
Indications for 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; pushes indicator to maximum displacement position. Indicator remains at peak value; user reads PEFR in liters per minute from logarithmic scale. Used by patients for self-monitoring; provides objective data for respiratory assessment.
Clinical Evidence
Bench testing only; device performance verified against November 1994 ATS Standards.
Technological Characteristics
Mechanical peak flow meter; logarithmic scale for increased resolution at low flow rates. Piston-spring mechanism. No electronic components or software.
Indications for Use
Indicated for patients requiring measurement of Peak Expiratory Flow Rate (PEFR) via forced exhalation maneuver to monitor respiratory function.
Regulatory Classification
Identification
A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.
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K963089
NOV - 6 1996
# 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: 518-561-7330 Fax: 518-561-5660
Contact: James A. Cochie
QA/RA Manager
**Date Prepared:** July 11, 1996
**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, #955262
## 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 changes in component dimensions necessary for the performance of the device to conform to the November 1994 ATS Standards update.
