Regulatory Text
21 C.F.R. § 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). [47 FR 31142, July 16, 1982, as amended at 67 FR 46852, July 17, 2002]
Source: ecfr.gov · govinfo.gov — public domain
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BS-CFR21-SEC-5A01CE
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Citation
21 C.F.R. § 868.2375
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CFR — Code of Federal Regulations
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The regulatory text of 21 C.F.R. § 868.2375 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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