21 C.F.R. § 870.2340 Electrocardiograph.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart C—Cardiovascular Monitoring Devices
§ 870.2340 Electrocardiograph.