Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 8 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER H - MEDICAL DEVICES
/ PART 870 - CARDIOVASCULAR DEVICES
/ Subpart B - Cardiovascular Diagnostic Devices / § 870.1425 Programmable diagnostic computer.
§ 870.1425 Programmable diagnostic computer.
(a) Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.
(b) Classification. Class II (performance standards).