← Product Code [CAF](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF) · K961973

# DHD ACE WITH MASK KIT (K961973)

_Dhd Diemolding Healthcare Div. · CAF · Aug 15, 1996 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF/K961973

## Device Facts

- **Applicant:** Dhd Diemolding Healthcare Div.
- **Product Code:** [CAF](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF.md)
- **Decision Date:** Aug 15, 1996
- **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/K961973](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF/K961973)

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