BIVONA VENTILATOR ISOLATOR SYSTEM
Device Facts
| Record ID | K890499 |
|---|---|
| Device Name | BIVONA VENTILATOR ISOLATOR SYSTEM |
| Applicant | Bivona Medical Technologies |
| Product Code | CAI · Anesthesiology |
| Decision Date | Jun 15, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5240 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.
