COMPUTERIZED SPIROMETRY SYSTEM
Device Facts
| Record ID | K823922 |
|---|---|
| Device Name | COMPUTERIZED SPIROMETRY SYSTEM |
| Applicant | Ohio Medical Products |
| Product Code | BZK · Anesthesiology |
| Decision Date | Feb 24, 1983 |
| 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.
