21 CFR § 870.1100 Cardiovascular Devices

§ 870.1100 Blood pressure alarm.

Current through Sep 8, 2026 · Read all of Part 870

⚠ 3 pending changes to Part 870

(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).

← § 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).§ 870.1110 Blood pressure computer. →