21 C.F.R. § 870.1100
Blood pressure alarm.
Cite as 21 C.F.R. § 870.1100 (2026)
(a) Identification. A blood pressure alarm is a device that accepts the signal from a blood pressure transducer amplifier, processes the signal, and emits an alarm when the blood pressure falls outside a pre-set upper or lower limit. (b) Classification. Class II (performance standards).