Code of Federal Regulations · Section
§ 870.2850 — Extravascular Blood Pressure Transducer
21 C.F.R. § 870.2850
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(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).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351