Code of Federal Regulations · Section

§ 870.1100 — Blood Pressure Alarm

21 C.F.R. § 870.1100

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(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).

Authorizing Statute