RESPIRE DISPOSABLE PULMONARY RESUSCITATOR
Device Facts
| Record ID | K913474 |
|---|---|
| Device Name | RESPIRE DISPOSABLE PULMONARY RESUSCITATOR |
| Applicant | Med-Tek Innovations, Inc. |
| Product Code | BTM · Anesthesiology |
| Decision Date | Feb 3, 1993 |
| 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.
