SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER
Device Facts
| Record ID | K862042 |
|---|---|
| Device Name | SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER |
| Applicant | Associated Mills, Inc. |
| Product Code | KFZ · Anesthesiology |
| Decision Date | Jun 5, 1986 |
| 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.
