NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR
Device Facts
| Record ID | K931542 |
|---|---|
| Device Name | NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR |
| Applicant | Newport Medical Instruments, Inc. |
| Product Code | BZK · Anesthesiology |
| Decision Date | Oct 25, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.1850 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.
