ARTEMA AQUA+
Device Facts
| Record ID | K912333 |
|---|---|
| Device Name | ARTEMA AQUA+ |
| Applicant | Artema Medical AB |
| Product Code | BYD · Anesthesiology |
| Decision Date | Jul 26, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5375 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.