FHB, FHB-T, FHBFLEX, FHBFLEX-T
Device Facts
| Record ID | K925622 |
|---|---|
| Device Name | FHB, FHB-T, FHBFLEX, FHBFLEX-T |
| Applicant | Icor AB |
| Product Code | BYD · Anesthesiology |
| Decision Date | May 26, 1993 |
| 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.
