← Product Code [BZH](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH) · K991212 # MODIFICATION TO TRUZONE PEAK FLOW METER (K991212) _Monaghan Medical Corp. · BZH · Jul 1, 1999 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K991212 ## Device Facts - **Applicant:** Monaghan Medical Corp. - **Product Code:** [BZH](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH.md) - **Decision Date:** Jul 1, 1999 - **Decision:** SESE - **Submission Type:** Abbreviated - **Regulation:** 21 CFR 868.1860 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology ## Indications for Use Portable monitoring device which measures the peak expiratory flow (PEF) generated by the patient during a forced exhalation maneuver. This measurement is useful in detecting changes in airways that could signal a worsening of symptoms or an improvement in breathing function for people with respiratory conditions such as Asthma or emphysema. ## Device Story TruZone Peak Flow Meter is a portable device for measuring peak expiratory flow (PEF) during forced exhalation. Used by patients with respiratory conditions like asthma or emphysema to monitor airway function. Device captures expiratory airflow; provides quantitative PEF measurement. Helps patients and clinicians track changes in breathing, signaling symptom worsening or improvement. Operates as a mechanical monitoring tool for respiratory assessment. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Portable mechanical peak flow meter designed for measuring peak expiratory flow (PEF). Device is a standalone, non-powered, handheld instrument. ## Regulatory Identification A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate. ## 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}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an abstract symbol of a human figure with three faces in profile, representing the department's focus on people and health. The seal is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL - 1 1999 Mr. James A. Cochie Monaghan Medical Corporation 5 Latour Avenue, Suite 1600 P.O. Box 2805 Plattsburgh, NY 12901-0299 K991212 Re: TruZone™ Peak Flow Meter Requlatory Class: II (two) Product Code: 73 BZH Dated: April 6, 1999 Received: April 9, 1999 Dear Mr. Cochie: We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {1}------------------------------------------------ Page 2 - Mr. James A. Cochie This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Thomas J. Callahan Thomas J. ( allahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Page 1 of 1 | 510(k) Number (if known): | K991212 | |---------------------------|---------| |---------------------------|---------| Device Name: __ TruZone™ Peak Flow Meter _____________________________________________________________________________________________________________________________________ Indications for Use: Portable monitoring device which measures the peak expiratory flow (PEF) generated by the patient during a forced exhalation maneuver. This measurement is useful in detecting changes in airways that could signal a worsening of symptoms or an improvement in breathing function for people with respiratory conditions such as Asthma or emphysema. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Atl. A. Ciarkowski. (Division Sign-Off) Division of Cardiovascular, Re and Neurological Devi 510(k) Number Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use_ or --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K991212](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K991212) **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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