HUMIDIFIER, WITH OR WITHOUT ADAPTER
Device Facts
| Record ID | K830896 |
|---|---|
| Device Name | HUMIDIFIER, WITH OR WITHOUT ADAPTER |
| Applicant | Airlife, Inc. |
| Product Code | KFZ · Anesthesiology |
| Decision Date | Apr 18, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5460 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A therapeutic humidifier for home use is a device that adds water vapor to breathing gases and that is intended for respiratory therapy or other medical purposes. The vapor produced by the device pervades the area surrounding the patient, who breathes the vapor during normal respiration.
