Title 21: Food and Drugs
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/ PART 868 - ANESTHESIOLOGY DEVICES
/ Subpart C - Monitoring Devices / § 868.2375 Breathing frequency monitor.
§ 868.2375 Breathing frequency monitor.
(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).