BE#1000-INSTANT ON/OFF O2 VALVE
Device Facts
| Record ID | K823408 |
|---|---|
| Device Name | BE#1000-INSTANT ON/OFF O2 VALVE |
| Applicant | Instrumentation Industries, Inc. |
| Product Code | BTM · Anesthesiology |
| Decision Date | Dec 7, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5915 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.
