21 CFR 870.2850 — Transducer, Blood-Pressure, Extravascular

Cardiovascular (CV) · Part 870 Subpart C—Cardiovascular Monitoring Devices · § 870.2850

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.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
DRSTransducer, Blood-Pressure, Extravascular21483rd Party
Innolitics

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