SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664
Device Facts
| Record ID | K851220 |
|---|---|
| Device Name | SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664 |
| Applicant | Northern Electric Co. Div. of Sunbeam Corp. |
| Product Code | KFZ · Anesthesiology |
| Decision Date | Sep 17, 1985 |
| 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.
