21 CFR 870.2880 — Transducer, Ultrasonic

Cardiovascular (CV) · Part 870 Subpart C—Cardiovascular Monitoring Devices · § 870.2880

Identification

An ultrasonic transducer is a device applied to the skin to transmit and receive ultrasonic energy that is used in conjunction with an echocardiograph to provide imaging of cardiovascular structures. This device includes phased arrays and two-dimensional scanning transducers.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
JOPTransducer, Ultrasonic2723rd Party
Innolitics

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