§868.2375. Breathing frequency monitor.
21 C.F.R. § 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. Class II (performance standards).
Notes, amendments, and revision history
Amendments
[47 FR 31142, July 16, 1982, as amended at 67 FR 46852, July 17, 2002]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 47 FR 31142, July 16, 1982, unless otherwise noted.
Amendments
[47 FR 31142, July 16, 1982, as amended at 67 FR 46852, July 17, 2002]