BEAR JET VENTILATOR FOR USE DURING (ESWL)
Device Facts
| Record ID | K871985 |
|---|---|
| Device Name | BEAR JET VENTILATOR FOR USE DURING (ESWL) |
| Applicant | Bear Medical Systems, Inc. |
| Product Code | CBK · Anesthesiology |
| Decision Date | Jun 15, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5895 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.
