21 CFR § 868.2375 Anesthesiology Devices

§ 868.2375 Breathing frequency monitor.

Current through Sep 8, 2026 · Read all of Part 868

(a) 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.

(b) Classification. Class II (performance standards).

[47 FR 31142, July 16, 1982, as amended at 67 FR 46852, July 17, 2002]

← § 868.2350 Gas calibration flowmeter.§ 868.2376 Device for sleep apnea testing based on mandibular movement. →