21 CFR 868.1850 — Spirometer, Monitoring (W/Wo Alarm)
Anesthesiology (AN) · Part 868 Subpart B—Diagnostic Devices · § 868.1850
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 2 | 61 | 3rd Party |
