21 CFR 868.2375 — Monitor, Breathing Frequency
Anesthesiology (AN) · Part 868 Subpart C—Monitoring Devices · § 868.2375
Identification
A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | 2 | 174 | 3rd Party |
| MNR | Ventilatory Effort Recorder | 2 | 160 | 3rd Party |
| PRK | Device Indicating An Exhalation Event | 2 | 1 | 3rd Party |
