MIST2GEN TEMPTROL 10
Device Facts
| Record ID | K801619 |
|---|---|
| Device Name | MIST2GEN TEMPTROL 10 |
| Applicant | Mistogen Equipment Co. |
| Product Code | BTT · Anesthesiology |
| Decision Date | Aug 4, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5450 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.
