§868.2377. Apnea monitor. — Inbound Citations
21 C.F.R. § 868.2377
Statutory Authority
Cited by 1 regulation in release Current.
Citations to 21 C.F.R. § 868.2377 as a whole
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(a) 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.