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 B—Cardiovascular Diagnostic Devices (§870.1025 to §870.1915) > 870.1450—Densitometer.

870.1450—Densitometer.

(a) Identification. A densitometer is a device used to measure the transmission of light through an indicator in a sample of blood.
(b) Classification. Class II (performance standards).