← Product Code [BZH](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH) · K963089 # TRUZONE PEAK FLOW METER (K963089) _Monaghan Medical Corp. · BZH · Nov 6, 1996 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K963089 ## Device Facts - **Applicant:** Monaghan Medical Corp. - **Product Code:** [BZH](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH.md) - **Decision Date:** Nov 6, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.1860 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology ## 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. ## Regulatory 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](/device/K926307.md)) - TruZone Peak Flow Meter ([K955262](/device/K955262.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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. --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K963089](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K963089) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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