← Product Code [BTI](/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI) · K883704 # MULTIICHALLENGE NEBULIZER SYSTEM (K883704) _Biotrine Corp. · BTI · Nov 28, 1988 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K883704 ## Device Facts - **Applicant:** Biotrine Corp. - **Product Code:** [BTI](/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI.md) - **Decision Date:** Nov 28, 1988 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.6250 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology ## Regulatory Identification A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K883704](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K883704) **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-g%E2%80%94miscellaneous/BTI/K883704