21 CFR 870.2400 - Vectorcardiograph.

Code of Federal Regulations - Title 21: Food and Drugs

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Title 21: Food and Drugs

CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER H: MEDICAL DEVICES

PART 870: CARDIOVASCULAR DEVICES

Subpart C: Cardiovascular Monitoring Devices

870.2400 - Vectorcardiograph.

(a) Identification. A vectorcardiograph is a device used to process the electrical signal transmitted through electrocardiograph electrodes and to produce a visual display of the magnitude and direction of the electrical signal produced by the heart.

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

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