← Product Code [CCQ](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ) · K892117

# GENTLEHALER(R) (K892117)

_Schering Research · CCQ · Jun 23, 1989 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K892117

## Device Facts

- **Applicant:** Schering Research
- **Product Code:** [CCQ](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ.md)
- **Decision Date:** Jun 23, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5640
- **Device Class:** Class 1
- **Review Panel:** Anesthesiology

## Regulatory Identification

A medicinal nonventilatory nebulizer (atomizer) is a device that is intended to spray liquid medication in aerosol form into the air that a patient will breathe.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K892117](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K892117)

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