21 C.F.R. § 868.2375 Breathing frequency monitor.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES
Subpart C—Monitoring Devices
§ 868.2375 Breathing frequency monitor.
