Code of Federal Regulations · Section
§ 870.2330 — Echocardiograph
21 C.F.R. § 870.2330
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(a) Identification. An echocardiograph is a device that uses ultrasonic energy to create images of cardiovascular structures. It includes phased arrays and two-dimensional scanners.
(b) Classification. Class II (performance standards).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351