PTR MK II VENTILATOR
Device Facts
| Record ID | K860692 |
|---|---|
| Device Name | PTR MK II VENTILATOR |
| Applicant | Bear Medical Systems, Inc. |
| Product Code | BYT · Anesthesiology |
| Decision Date | May 21, 1986 |
| 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.
