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e-CFR data is current as of August 12, 2020

Title 21Chapter ISubchapter HPart 870Subpart E → §870.4220


Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart E—Cardiovascular Surgical Devices


§870.4220   Cardiopulmonary bypass heart-lung machine console.

(a) Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.

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

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