← Product Code [BZK](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK) · K884942 # MONAGHAN RVM, MODEL 761 (K884942) _Monaghan Medical Corp. · BZK · Jun 7, 1989 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K884942 ## Device Facts - **Applicant:** Monaghan Medical Corp. - **Product Code:** [BZK](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK.md) - **Decision Date:** Jun 7, 1989 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.1850 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology ## Regulatory Identification A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status. --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K884942](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K884942) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K884942