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Electronic Code of Federal Regulations

e-CFR data is current as of February 26, 2020

Title 21Chapter ISubchapter HPart 870Subpart B → §870.1435


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


§870.1435   Single-function, preprogrammed diagnostic computer.

(a) Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.

(b) Classification. Class II (performance standards).

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