← Product Code [CAF](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF) · K943990

# 3000 AEROSOL TWO (K943990)

_Medical Industries America, Inc. · CAF · Mar 21, 1995 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF/K943990

## Device Facts

- **Applicant:** Medical Industries America, Inc.
- **Product Code:** [CAF](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF.md)
- **Decision Date:** Mar 21, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5630
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF/K943990](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF/K943990)

**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:** Innolitics at https://innolitics.com