THERASTEAM PERSONAL STEAM INHALER
Device Facts
| Record ID | K950116 |
|---|---|
| Device Name | THERASTEAM PERSONAL STEAM INHALER |
| Applicant | Kaz, Inc. |
| Product Code | KFZ · Anesthesiology |
| Decision Date | Feb 10, 1995 |
| 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.
