eCFR Reference Browser

---

title: "21 CFR §870.2880"

source: "https://www.ecfr.gov/current/title-21/section-870.2880"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "870"

part_subject: "CARDIOVASCULAR DEVICES"

subpart_code: "C"

subpart_subject: "Cardiovascular Monitoring Devices"

section_number: "870.2880"

section_subject: "Ultrasonic transducer."

cfr_reference: "21 CFR 870.2880"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(a)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.

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

§870.2880 - Ultrasonic transducer.