NEV-10 NEGATIVE PRESSURE VENTILATOR
Device Facts
| Record ID | K910947 |
|---|---|
| Device Name | NEV-10 NEGATIVE PRESSURE VENTILATOR |
| Applicant | Lifecare Services, Inc. |
| Product Code | BYT · Anesthesiology |
| Decision Date | Jun 3, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5935 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An external negative pressure ventilator (e.g., iron lung, cuirass) is a device chamber that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient.
