1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 870 - CARDIOVASCULAR DEVICES
  6. Subpart B - Cardiovascular Diagnostic Devices
  7. 21 CFR § 870.1450
21 CFR § 870.1450
Densitometer
June 25, 2020
CFR

(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).

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§ 870.1435 Single-function, preprogrammed diagnostic computer
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§ 870.1650 Angiographic injector and syringe

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