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).