MODIFIED AEROCHAMBER WITH MASK
Device Facts
| Record ID | K900576 |
|---|---|
| Device Name | MODIFIED AEROCHAMBER WITH MASK |
| Applicant | Monaghan Medical Corp. |
| Product Code | CCQ · Anesthesiology |
| Decision Date | May 13, 1991 |
| 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.