← Product Code [CAF](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF) · K972371

# ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR (K972371)

_Brasamerica Medical Equipment, Inc. · CAF · Aug 19, 1997 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF/K972371

## Device Facts

- **Applicant:** Brasamerica Medical Equipment, Inc.
- **Product Code:** [CAF](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF.md)
- **Decision Date:** Aug 19, 1997
- **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.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF/K972371](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF/K972371)

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