CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 870—CARDIOVASCULAR DEVICES > SUBPART E—Cardiovascular Surgical Devices (§870.4075 to §870.4885) > 870.4330—Cardiopulmonary bypass on-line blood gas monitor.

870.4330—Cardiopulmonary bypass on-line blood gas monitor.

(a) Identification. A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood.
(b) Classification. Class II (performance standards).