ERA 2000A
Device Facts
| Record ID | K911261 |
|---|---|
| Device Name | ERA 2000A |
| Applicant | Neotronics, Inc. |
| Product Code | BTL · Anesthesiology |
| Decision Date | May 31, 1991 |
| 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.
