GENTLEHALER(R)
Device Facts
| Record ID | K892117 |
|---|---|
| Device Name | GENTLEHALER(R) |
| Applicant | Schering Research |
| Product Code | CCQ · Anesthesiology |
| Decision Date | Jun 23, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5640 |
| Device Class | Class 1 |
Regulatory Classification
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.
