Q101 DIAGNOSTIC SPIROMETER
Device Facts
| Record ID | K863300 |
|---|---|
| Device Name | Q101 DIAGNOSTIC SPIROMETER |
| Applicant | Quinton, Inc. |
| Product Code | BYT · Anesthesiology |
| Decision Date | Nov 13, 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.
