FLYNNR GENESIS II A/C, A/O AND IDLH
Device Facts
| Record ID | K932170 |
|---|---|
| Device Name | FLYNNR GENESIS II A/C, A/O AND IDLH |
| Applicant | O-Two Systems Intl., Inc. |
| Product Code | BTL · Anesthesiology |
| Decision Date | Oct 25, 1993 |
| 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.
