THE BREATHER
Device Facts
| Record ID | K944412 |
|---|---|
| Device Name | THE BREATHER |
| Applicant | Pal Medical, Inc. |
| Product Code | BWF · Anesthesiology |
| Decision Date | Apr 26, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5690 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.
