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Electronic Code of Federal Regulations

e-CFR data is current as of February 21, 2020

Title 21Chapter ISubchapter HPart 870Subpart B → §870.1425


Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart B—Cardiovascular Diagnostic Devices


§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).

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