VERSION OF A CLOSED-FLOW SYS. CALORIC
Device Facts
| Record ID | K813490 |
|---|---|
| Device Name | VERSION OF A CLOSED-FLOW SYS. CALORIC |
| Applicant | Thomas M. Foti, M.D. |
| Product Code | ETF · Ear, Nose, Throat |
| Decision Date | Jan 7, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.5300 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An ear, nose, and throat examination and treatment unit is an AC-powered device intended to support a patient during an otologic examination while providing specialized features for examination and treatment. The unit consists of a patient chair and table, drawers for equipment, suction and blowing apparatus, and receptacles for connection of specialized lights and examining instruments.
