DISPOSABLE INCENTIVE SPIROMETER
Device Facts
| Record ID | K781394 |
|---|---|
| Device Name | DISPOSABLE INCENTIVE SPIROMETER |
| Applicant | Inhal-O-Tech Medical Plastic |
| Product Code | CCQ · Anesthesiology |
| Decision Date | Oct 16, 1978 |
| 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.