← Product Code [CBK](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK) · K884389 # MODIFIED 225/SIMV VOLUME VENTILATOR (K884389) _Monaghan Medical Corp. · CBK · Mar 12, 1990 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K884389 ## Device Facts - **Applicant:** Monaghan Medical Corp. - **Product Code:** [CBK](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK.md) - **Decision Date:** Mar 12, 1990 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5895 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology ## Regulatory Identification A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device. --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K884389](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K884389) **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-f%E2%80%94therapeutic-devices/CBK/K884389