RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIED
Device Facts
| Record ID | K921002 |
|---|---|
| Device Name | RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIED |
| Applicant | Rondex Products, Inc. |
| Product Code | BTM · Anesthesiology |
| Decision Date | Oct 6, 1992 |
| 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.
