SMOOTH-FLO CIRCUIT
Device Facts
| Record ID | K010402 |
|---|---|
| Device Name | SMOOTH-FLO CIRCUIT |
| Applicant | Hudson Respiratory Care, Inc. |
| Product Code | BTT · Anesthesiology |
| Decision Date | Mar 14, 2001 |
| Decision | SESE |
| Submission Type | Special |
| 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.
