21 CFR § 870.2850 - Extravascular blood pressure transducer.

(a) Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.

(b) Classification. Class II (performance standards).