← Product Code [CAF](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF) · K800562

# DISPOSABLE HAND HELD NEBULIZER (K800562)

_Intec Medical, Inc. · CAF · Mar 25, 1980 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF/K800562

## Device Facts

- **Applicant:** Intec Medical, Inc.
- **Product Code:** [CAF](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF.md)
- **Decision Date:** Mar 25, 1980
- **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/K800562](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF/K800562)

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