CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 870—CARDIOVASCULAR DEVICES > SUBPART C—Cardiovascular Monitoring Devices (§870.2050 to §870.2920) > 870.2050—Biopotential amplifier and signal conditioner.

870.2050—Biopotential amplifier and signal conditioner.

(a) Identification. A biopotential amplifier and signal conditioner is a device used to amplify or condition an electrical signal of biologic origin.
(b) Classification. Class II (performance standards).