Code of Federal Regulations · Section
§ 870.2340 — Electrocardiograph
21 C.F.R. § 870.2340
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(a) Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.
(b) Classification. Class II (performance standards).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351