UNI-VENT MODEL 73X
Device Facts
| Record ID | K051476 |
|---|---|
| Device Name | UNI-VENT MODEL 73X |
| Applicant | Impact Instrumentation, Inc. |
| Product Code | BTL · Anesthesiology |
| Decision Date | Oct 28, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5925 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.