RESPITRACE
Device Facts
| Record ID | K772016 |
|---|---|
| Device Name | RESPITRACE |
| Applicant | Respitrace Corp. |
| Product Code | BZK · Anesthesiology |
| Decision Date | Jan 26, 1978 |
| 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.
